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Medical Whistleblower Advocacy Network

Human Rights Defenders

Non-Consensual Treatment and Pharmaceutical Off-label Promotion and Misbranding

Medical Whistleblower Advocacy Network

 

Submission to the

 

United Nations’ Open-ended Intergovernmental Working Group on

 

Transnational Corporations and Other Business Enterprises with Respect to Human Rights

 

August 30, 2017

Non-Consensual Treatment and Pharmaceutical Off-label Promotion and Misbranding

 

Prohibition of torture or non-consensual experimentation

 

One of the most fundamental, absolute and non-derogable rights is the Right to freedom from torture or cruel, inhuman or degrading treatment or punishment and from medical or scientific experimentation. Everyone has the right to free prior informed consent to medical treatment, including individuals with a mental health disability. The Right to not be subjected medical or scientific experimentation without one’s free consent is absolute, non-derogable, ius cognens and erga omnes.

 

Non-consensual human medical experimentation, which violates one's rights to life, health, and personal integrity, is universally condemned as a violation of customary and codified international law.

 

The involuntary administration of the off-label misbranded drugs violates Article 7 of the ICCPR as well as the ethical standards set by the Nuremberg Code and the Declaration of Helsinki.

United States and Treaty Law

 

The Right to freedom from torture or cruel, inhuman or degrading treatment or punishment and freedom from medical or scientific experimentation is a human rights principle that has the status of jus cogens, and thus is ipso facto entrenched against treaty amendment or repeal.

 

Article 53 of Vienna Convention on The Law of Treaties (Signed at Vienna 23 May 1969), stated that “For the purposes of the present Convention, a peremptory norm of general international law is a norm accepted and recognized by the international community of States as a whole as a norm from which no derogation is permitted and which can be modified only by a subsequent norm of general international law having the same character.”

 

The United States has signed and ratified the International Covenant on Civil and Political Rights (ICCPR) and The Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (the United Nations Convention against Torture or CAT). Both treaties delineate the prohibition against torture. The ICCPR specifically identifies non-consensual experimentation within Article 7 of the ICCPR.

 

“No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”

 

Art. 2 of the ICCPR states that ‘[e]ach State Party… undertakes to respect and to ensure to all individuals within its territory and subject to its jurisdiction the rights recognized in the present Covenant ...’

 

The ICCPR contains no provision on termination or withdrawal, and the Human Rights Committee in General Comment 26 of 1997 declared that there was no such intention so that a state may not withdraw from it.

 

Finally, Article 103 of the UN Charter provides that ‘[i]n the event of a conflict between the obligations of the Members of the United Nations under the present Charter and their obligations under any other international agreement, their obligations under the present Charter shall prevail’.

 

The ICCPR treaty should be interpreted in good faith and with liberal interpretation in order to protect the human rights of vulnerable persons. The canon of good faith stipulates that treaties “are to be kept in most scrupulous good faith,” and that a treaty “should be interpreted . . . in a manner to carry out its manifest purpose.”

 

If a treaty such as the ICCPR has the status of supreme federal law, and it creates or protects individual rights, then an individual whose rights under the treaty have been violated is entitled to a domestic judicial remedy. The Supremacy Clause supplements international law mechanisms for enforcing treaties by adding domestic mechanisms. The Supremacy Clause causes treaties to be assimilated treaties to federal statutes and the Constitution (the national legal system), thus obviating the differences in enforcement mechanisms that would otherwise exist between these forms of law. Among other things, the Supremacy Clause makes treaties enforceable in court at the request of individuals. Because it refers to “Judges,” the Supremacy Clause clearly contemplates that courts will enforce treaties, and, indeed, “[t]he province of the court is, solely, to decide on the rights of individuals.”

 

Chief Justice Marshall in Foster v. Neilson 1 recognized that our Constitution, specifically the Supremacy Clause, establishes the general rule that treaties are enforceable in U.S. courts, just as the Constitution and federal statutes are.

 

Purposes and objectives of the U.S. Congress regarding human rights

 

International Human Right Treaties signed and ratified by the United States clearly are a statement of the U.S. Congress’s purposes and objectives in regard to human rights.

 

Thus, an interpretation of the United States obligations under the International Covenant on Civil and Political Rights (ICCPR), in conjunction with the ethical and legal standards of the United States Constitution and the U.S. Bill of Rights a natural person and citizen of the U.S.A., has the right to bring a petition to the Inter-American Commission on Human Rights in support of his/her human rights as defined under International Human Rights law and the customary human rights norms.

 

Certain rights, such as the right to freedom from torture and freedom from non-consensual experimentation, are non-derogable, and as such, cannot be suspended even in times of national emergency. Human rights such as the prohibition against crimes against humanity, torture and non-consensual scientific or medical experimentation are considered to be absolute. There are implied erga omnes duties for the United States to prohibit non-consensual experimentation and torture.

 

The principle of the prohibition against non-consensual experimentation to be fundamentally norm-creating character and the widespread practice of protecting human subjects is considered legally or morally obligatory - Opinio Iuris.

 

The United States Congress has clearly indicated through the ratification of the ICCPR, (Article 7) that it is the purpose and the intent of Congress to protect persons from non-consensual experimentation.

 

The United States Congress has also implemented Article 7 of the ICCPR in domestic legislation to protect human subjects from non-consensual experimentation – The Common Rule (45 CFR Part 46). The United States Congress has made its intent clearly evident by 1) ratifying the ICCPR (including Article 7), 2) Holding extensive discussions regarding the ethical need for human subjects protections, 3) publishing The Belmont Report and 4) legislating The Common Rule.

 

The Common Rule (45 CFR Part 46) is federal legislation drafted and entered in force under proper constitutional procedures and thus it is enforceable by the Court.

 

By legislating The Common Rule through a thorough and detailed political process the United States federal government has expressed the political will of the people to protect and defend the rights of persons against non-consensual experimentation.

 

Domestic Legislation

 

On July 12, 1974, the United States National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.

 

The Belmont Report (1976) 2 is a formal statement by the United States government regarding the ethical standards and accepted legal norms regarding the use of human subjects in medical, behavioral or scientific experimentation. The Belmont Report summarizes the basic ethical principles identified in 4 days of deliberations supplemented by the monthly deliberations held over a period of nearly four years. It is a statement of basic ethical principles and guidelines to consider in the use of human subjects in research. It was published in the Federal Register so it could become ethical guidance for U.S. researchers, scientists, governmental employees and Institutional Review Boards (IRB).

 

The Belmont Report identifies three basic ethical principles that are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

 

 

Research vs Medical Practice

 

Medical practice is meant to enhance the well-being of an individual patient or client and is expected to have a reasonable expectation of success. The purpose of medical, psychological or psychiatric practice is to provide diagnosis, preventive treatment or therapy to individuals. Within clinical medical practice, physicians are ethically required to obtain free prior informed consent for any treatment.

 

Free prior informed consent for treatment is especially important when a clinician departs in any significant way from standard or accepted practice, or utilizes a medication that the FDA has not approved for that use. Although medical professionals can use a medication that is "experimental," (in the sense of being new, untested or different), this does not absolve the physician from disclosing to the patient the possible risks and benefits of treatment and obtaining free prior informed consent. Failure to obtain proper and legal free, prior and informed consent is considered medical malpractice.

 

The process of obtaining consent must involve three elements: information, comprehension and voluntariness. Consent obtained by deceit, misinformation, or coercion is not legally valid. Information supplied in English to a patient whose only language is Spanish does not comply with the comprehension aspect of informed consent. Providing information only in very detailed scientific terminology that is not understood by lay person, is also not complying with the comprehension aspect of informed consent. Without free prior informed consent, experimental treatment on human subjects is prohibited by U.S. law. Radically new medications should be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees to demand that the ethical principles of the Belmont Report are applied and human rights of patients are protected.

 

The United States has accepted as an ethical standard the prohibition of non-consensual scientific or medical experimentation by promulgating federal laws which expressly prohibit such practices – The Common Rule – “The Federal Policy for the Protection of Human Subjects.” The Common Rule (45 CFR Part 46) was adopted in 1991.

 

The FDA, Off Label Promotion and Misbranding

 

In the United States new drugs are tested in clinical trials (research studies) before they are approved by the US Food and Drug Administration (FDA) for use in the general public.

 

The clinical trials are done to show that the drug:

  • Works to treat a certain medical condition

  • Works the way it’s expected to

  • Is safe when used as directed

 

When the FDA is satisfied that the drug works and is safe, it and the maker of the drug create the drug label. This is not an actual label that sticks to a bottle, but a report of very specific information about the drug. The FDA must approve this report, which is made available to all health professionals who prescribe or sell the drug. The drug label gives information about the drug, including the specific medical condition(s) it’s approved for (called the indication(s) for use), the doses to be used, and how it’s to be given. When a drug is used in a way that is different from that described in the FDA-approved drug label, it’s said to be an “off-label” use.

 

This can mean that the drug is:

  • Used for a different disease or medical condition

  • Given in a different way (such as by a different route)

  • Given in a different dose than in the approved label

 

The off-label use of FDA-approved drugs is not regulated, but it is legal in the United States and many other countries. While it’s legal for doctors to use drugs off label, it’s not legal for drug companies to market (advertise or promote) their drugs for off-label uses. Off-label marketing is very different from off-label use. Some of the problems of off-label drug use is that it often does not reflect “standard of care” treatment. This could cause a patient have an unwanted or bad outcome from the treatment. The FDA does not regulate the practice of medicine. In general, once the FDA approves a drug, licensed doctors can use it for any purpose they consider medically appropriate.

 

One of the biggest problems related to widespread off-label use is the lack of information about how to best use the drug other than for what it was approved. The drug label contains the information that’s been approved by the FDA, and it does not cover off-label uses. Lack of information on off-label drug use and outcomes puts patients at a higher risk for medication errors, side effects, and unwanted drug reactions. For proper medical use of an off labeled drug, the doctor should adequately inform the patient about the possible risks of using the drug and weigh them against the possible benefits. When a court of law decides that a patient should receive off-label drug medical treatment, the process of obtaining prior, free and informed consent does not occur. Off label promotion of misbranded prescription medications is very common in the vulnerable population of persons who are wards of the court because of the low risk of detection and low risk of medical malpractice liability.3

 

Off-label promotion can involve the following: 1) Paying incentives to sales representatives based on sales for off-label use;4 2) Paying kickbacks to physicians to prescribe drugs for off-label use; 5 3) Disseminating misleading posters promoting off-label use; 6 4) Paying physicians: (a) To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents; (b) To serve as members of “advisory boards” promoting off-label use; (c) To travel to resort locations to listen to promotions about off-label use; or (d) To give promotional lectures in favor of off-label use to fellow practitioners.7 5) Providing advice to prescribers on how to code their claims and document their medical records to support payment for off-label uses not covered by Medicaid;8 6) Publicizing studies showing efficacy of off-label uses while suppressing studies showing no efficacy;9 and 7) Making false representations directly to Medicaid to influence decisions about payment for drugs used off-label.10

 

Right To Health And Freedom Of Information

 

In 2009 the Special Rapporteur on the Right to health stressed that the right to health is contingent on the right to access to information. The Special Rapporteur stated that informed consent is a “voluntary and sufficiently informed decision, protecting the right of the patient to be involved in medical decision-making, and assigning associated duties and obligations to health-care providers.” The right to receive and impart information is an integral element of the right to health. Completeness of information is among the required components of informed consent.

 

To obtain prior informed consent requires disclosure of the associated benefits, risks and alternatives to a medical procedure. The accuracy and completeness of information is necessary for valid informed consent for medical treatment. Without truthful scientific information about the associated benefits, risks and alternatives to a medical procedure or treatment is required for consent to be valid. The guarantee of informed consent is to respect the autonomy, self-determination and human dignity of individuals. It constitutes a violation of a patient’s right to health to act, or fail to act, in a way that deprives that patient from the information he or she needs to provide informed consent.

 

In addition, the withholding of the facts presented in the mental health evaluation which was used to certify the Petitioner as legally incapacitated, is also a violation of Article 13 of the American Convention. Without the facts it is impossible to mount a legal defense for the patient. The Inter-American Commission on Human Rights has established the principle that “every person has the right to access to information about himself or herself.” States within the context of the American Convention therefore must guarantee the exercise of this right. The Inter-American Court of Human Rights stipulated the right to “seek” and “receive” “information”, as per Article 13 of the Convention protects the right of all individuals to request access to State-held information. This includes the right of the individual to receive such information and the positive obligation of the State to provide it.

 

In a landmark case Claude-Reyes et al v Chile, Freedom of thought and expression is also protected by Articles IV of the American Declaration and 13 of the American Convention.

 

The UN Convention on the Rights of Persons with Disabilities was adopted to promote, protect, and ensure the full and enjoyment of human rights and fundamental freedoms by all persons with disabilities and to promote respect for their inherent dignity. Parties to the CRPD must ensure that persons with disabilities are able to exercise the right to freedom of expression and that includes “the freedom to seek, receive and impart information and ideas on an equal basis with others and through all forms of communication of their choice.”

 

Access to truthful scientific medical information is essential to patient informed consent. Unimpaired access to medical information is necessary in the fight against pharmaceutical corruption and medical fraud, and impacts the public health. By encouraging and creating a more transparent system for the distribution of medical information to the public, and demanding criminal accountability for the deceptive off label promotion efforts by the pharmaceutical industry, the United States could start eliminating corruption in the pharmaceutical marketing and health care systems.

 

In 1990, the Pan American Health Organization (PAHO/WHO) – the World Health Organization’s (WHO) Regional Office of the Americas and a specialized agency of the Organization of American States (OAS)–sponsored the Regional Conference on Restructuring Psychiatric Care in Latin America, with the IACHR as a co-sponsor. At that conference, the Declaration of Caracas was adopted. The Declaration of Caracas establishes standards on protecting human rights and mental health. Regarding psychiatric care, it indicates that the “resources, care and treatment that are made available must safeguard personal dignity and human and civil rights … and strive to ensure that patients remain in their communities”. It also recommends that countries redraft national legislation to ensure that the “human and civil rights of the mental patients are safeguarded.”

 

In April 1999, the Inter-American Commission on Human Rights approved Report No 63/99 in the case of a person with a mental disorder. That report finds that it is “pertinent to apply special standards to the determination of whether the provisions of the Convention have been complied with in cases involving persons suffering from mental illnesses” or detainees in psychiatric hospitals, who are considered to be a particularly vulnerable group. In that report, the IACHR interpreted the standards of the American Convention that provide for the right to physical integrity, the right to life, and the right to judicial protection in light of the Mental Health Principles. In that report, the IACHR also agreed with the position of the European Court of Human Rights, which has established that the state of health of a victim is an important factor in determining whether they have been subjected to inhumane or degrading punishment or treatment and therefore concluded that the incarceration of a mentally disabled person under deplorable conditions and without medical treatment may be considered as inhumane or degrading treatment, prohibited under Article 5(2) of the American Convention on Human Rights.

Criminal Misbranding and Off Label Promotion

 

The pharmaceutical companies have an extensive history of criminal off label promotion of their psychiatric medications. Off-label marketing of medications is the promotion of these drugs for uses that have never been approved by the Food and Drug Administration, and for which they had not been proven to be either safe or effective. The off-label use of these medications increased in adolescents, due to an organized effort by the pharmaceutical industry to proactively increase the diagnosis of depression in teenagers. One way they did this was through the “Teen Screen” program done through the public school system.

The public did not realize that these off-label uses had never been approved by the FDA. Pharmaceutical research financing is an important part of the budget of mental health facilities. Patients are without their prior informed consent, enrolled in clinical experimental trials financed and controlled by the pharmaceutical companies. Doctors do not go through the necessary steps required to protect the patient’s rights for human subjects in medical experimentation as required under The Common Rule. Patients are often not informed at all about the experimental use of the medication. This continues to be common practice within psychiatric hospitals and mental health clinics where they do emergency mental health interventions. Even in private practice, mental health professionals do not get patient’s prior informed consent prior to enrolling the patient into poorly supervised experimental off-label clinical use. Patients do not realize that these medications had not been proven safe or effective and the use of these products was essentially clinical experimental use of the product by their personal physicians.

Pharmaceutical companies are currently being criminally convicted by the U.S. Department of Justice of gross misrepresentations of their drug’s safety and efficacy and misbranding of their product. FDA can pursue misbranding cases criminally, and the consequences can be severe, especially when the FDA believes that the violation was committed with the intent to defraud or mislead.

Federal law in the United States - 21 USC § 331 makes clear that federal law prohibits “the introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded,” and “the adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.” Additionally, 21 USC § 352(f) provides that a drug will be deemed to be misbranded unless its labeling contains adequate directions for use, which typically requires the directions to allow a layperson to use the drug safely and for the purposes for which it was intended.

In one recent case in 2012 for example, Abbott Laboratories Inc. plead guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability for their off label promotion of Depakote. Abbott promoted Depakote to control behaviors in elderly dementia and schizophrenia patients without significant evidence of its effectiveness for that use, and even after clinical data established that it was not effective. The resolution includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. Abbott also will be subject to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.

Separate from the DOJ settlement, Abbott agreed to pay 45 states a total of $100 million to resolve liability under the state consumer-protection laws. That makes this the second-largest fraud settlement involving a drug company, behind only the $2.3 billion Pfizer settlement in 2010.

The company maintained a specialized sales force to market Depakote for off label purposes; targeting elderly dementia patients in nursing homes. Abbott has pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved. The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. The FDA never approved the drug as safe and effective for the off-label use of controlling behavioral disturbances in dementia patients.

In 1999, Abbott was forced to discontinue a clinical trial of Depakote in the treatment of dementia due to an increased incidence of adverse events, including somnolence (sleepiness), dehydration and anorexia (loss of appetite) experienced by the elderly study participants administered Depakote.

Abbott’s off-label promotion of Depakote was multifaceted. Abbott trained its sales force to promote Depakote to health care providers and employees of nursing homes as advantageous over antipsychotic drugs for controlling agitation and aggression in elderly dementia patients because Depakote was not subject to certain provisions of the Omnibus Budget Reconciliation Act of 1987 (OBRA). OBRA’s implementing regulations were designed to prevent the use of unnecessary medications in nursing homes. Exploiting the fact that certain OBRA provisions did not yet apply to Depakote, Abbott sales representatives stated that by using Depakote, nursing homes could avoid the administrative burdens and costs of complying with OBRA.

The company entered into contracts that provided long-term care pharmacy providers with payments of rebates based on increases in the use of Depakote in nursing homes serviced by the providers. The company wound up giving millions of dollars in rebates to pharmacists at long-term-care facilities that were based on increases in the use of the drug in nursing homes they serviced. Abbott created programs and materials to train the pharmacy providers' consultant pharmacists about the off-label use of Depakote to encourage them to recommend the drug for this unapproved use. Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies, putting profits ahead of patient safety. Abbott offered and paid illegal remuneration to health care professionals and long term care pharmacy providers to unduly influence the content of company sponsored Continuing Medical Education programs, in violation of the Federal Anti-Kickback Statute.

In the agreed statement of facts, Abbott also admitted that from 2001 through 2006, the Company misbranded Depakote by marketing the drug to treat schizophrenia. Abbott funded two scientific studies of the use of Depakote to treat schizophrenia, and both failed to meet the main goals established for the study. When the second study failed to show a statistically significant treatment difference between antipsychotic drugs used in combination with Depakote and antipsychotic drugs alone, Abbott waited nearly two years to notify its own sales force about the study results and another two years to publish those results. During this time, Abbott continued to promote Depakote off-label to treat schizophrenia.

In another criminal case, Pfizer paid $1.3 billion in criminal fines for “misbranding” (the legal term for off-label marketing) drugs. And that was just the tip of the iceberg, considering the total package of the settlement was $2.3 billion when adding in Department of Justice (DOJ) fees and costs. The fine was so high because Pfizer was considered a “repeat offender” after it continued to promote Lipitor and Viagra for off-label uses following a request to cease and desist these practices by the FDA.

Large criminal fines of billions of dollars were awarded by the courts, but this did little to effectively curtail the direct marketing of these off-label uses of pharmaceutical products to consumers and to medical professionals. Drug manufacturers consider the monetary penalties as just another cost of doing business. So pharmaceutical companies continue to collect huge sums of profit from the allegedly illegal acts and even after the criminal convictions. Patients are not withdrawn from these dangerous medications. Instead, Medicaid and Medicare continue to pay for these off label medications for treatment of wards of the court (even after criminal prosecution). Judges who run mental health courts are not warned by the Department of Justice that the drugs they are forcing on wards of the court have been proven to be dangerous to patients and the pharmaceutical company criminally convicted.

Because the judgment and settlement penalties proved to be ineffective deterrents of these practices, the FDA and DOJ started to find other ways to try to stop the manufacturers from on-going unlawful activities. The federal agencies have begun to employ two new strategies: 1) bringing criminal charges against wayward company executives, and 2) barring the offending manufacturers from doing any business with or for the various and multiple federal prescription benefit plans (e.g., Medicare, Medicaid). The U.S. federal government is the largest single purchaser of drugs in the world.

The involvement of the court system to enforce these new deterrents is absolutely crucial. Thus the probate judges should enforce the patient’s right to free prior informed consent and the right to be free from non-consensual experimentation.

 

Discrimination against the disabled and need for protection

 

Persons with mental disabilities are often discriminated by reason of their condition. According to the Inter-American Convention on the Elimination of All Forms of Discrimination against Persons with Disabilities, States are obligated to properly supervise care and take actions necessary prevent all types of discrimination. Patients who live in psychiatric institutions or are undergoing treatment therein, are particularly vulnerable to torture and other types of cruel, inhuman or degrading treatment. These persons are more susceptible to mistreatment when hospitalized. The autonomy and right to self-determination of patients is severely curtailed in healthcare institutions which impinges on personal integrity. The States have the duty to supervise and guarantee that in all psychiatric institutions, either public or private, the patients´ right to receive a worthy, humane, and professional treatment be preserved and that said patients be protected against exploitation, abuse, and degradation. States are also obligated to promote the full integration of such persons in society. 11 The rights of the disabled are delineated in federal policy and law most notably in the Americans with Disabilities Act (ADA).

 

The international human rights treaty – The Convention on the Rights of Persons with Disabilities (CRPD) was signed by the President of the United States, Barack Obama.12 Article 12 of the CRPD affirms the equal recognition before the law and legal capacity of the persons with disabilities. Article 13 of the CRPD affirms the effective access to justice for persons with disabilities. Article 25 specifies that "persons with disabilities have the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability." The Convention on the Rights of Persons with Disabilities (CRPD) also protects the integrity of the person. Article 17 of the CRPD states that every person with disabilities has a right to respect for his or her physical and mental integrity on an equal basis with others.

 

Regarding individuals in psychiatric treatment, the United States cannot completely absolve itself of its responsibilities under international treaty law by delegating legal responsibility for determinations of legal capacity and guardianship to the law of the state rather than by federal law. The federal government of the United States still has the obligation to guarantee and protect human rights and to ensure humane treatment. That legal capacity and guardianship are governed by the law of the state members of the United States of America, and not by federal law, does not absolve the federal government of its responsibility. The United States, as a nation state, still retains a duty to exercise supervision and control over public and private psychiatric institutions. The judicial system or judicial branch of government and administrative institutions of the United States must not only provide competent supervision on a regular basis of the confinement and medical treatment, but also whether it is justified.13

 

1 Foster v. Neilson, 27 U.S. (1 Pet.) 253, 314 (1829)

2 The Belmont Report was published in the Federal Register, and reprints are provided upon request to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

3 Overprescribed: The Human and Taxpayers’ Costs of Antipsychotics in Nursing Homes. (2011, November 30). Hearing Before the Senate Special Committee on Aging. [Testimony of Daniel R. Levinson, Inspector General of the Department of Health and Human Services] http://oig.hhs.gov/testimony/docs/2011/levinson_testimony_11302011.pdf

4 U.S. Department of Justice. (2013, July 30). Wyeth Pharmaceuticals Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2013/July/13-civ-860.html

5 U.S. Department of Justice. (2010, April 27). Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing. [Para. 10]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/April/10-civ-487.html

6 U.S. Department of Justice. (2011, June 9). U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/June/11civ-751.html

7 U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

8 U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

9 U.S. Department of Justice. (2011, March 2). Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations. [Para. 8]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/March/11-civ-270.html

10 U.S. Department of Justice. (2012, April 19). U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx. [Para. 5]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2012/April/12civ-497.html

11 Inter-American Convention on the Elimination of All Forms of Discrimination against Persons with Disabilities, supra note 35, Preamble and Article III (1).

12 Article 12 of the Convention affirms the equal recognition before the law and legal capacity of the persons with disabilities. States Parties should: 1) Reaffirm that persons with disabilities have the right to recognition everywhere as a person before the law. 2) Recognize that persons with disabilities enjoy legal capacity on an equal basis with others in all aspects of life. 3) Take appropriate measures to provide access by persons with disabilities to the support they may require in exercising their legal capacity. 4) Ensure that all measures that relate to the exercise of legal capacity provide for appropriate and effective safeguards to prevent abuse in accordance with international human rights law. Such safeguards shall ensure that measures relating to the exercise of legal capacity respect the rights, will and preferences of the person, are free of conflict of interest and undue influence, are proportional and tailored to the person's circumstance, apply for the shortest time possible and are subject to regular review by a competent, independent and impartial authority or judicial body. The safeguards shall be proportional to the degree to which such measures affect the person's rights and interests.

13 European Court of Human Rights, Case of Storck v. Germany, Application No. 61603/00, judgment of June 16, 2005, p. 103.

 


  Presentación al

 

Grupo de Trabajo Intergubernamental de Composición Abierta de las Naciones Unidas sobre las empresas transnacionales y otras empresas comerciales en el ámbito de los derechos humanos

 

8/30/17

 

El tratamiento [medico] no Consensual y la Promoción [de Medicamentos] Sin Etiqueta y Marcados Erróneamente [Off-label Promotion and Misbranding]

 

La Experimentación no Consensual y la Promoción [de Medicamentos] Sin Etiqueta y Marcados Erróneamente

[Off Label and Misbranded]

 

 

Prohibición de la Tortura o de la Experimentación no Consensual

 

Uno de los derechos más fundamentales, absolutos y no derogables es el derecho a no ser sometido a tortura ni a tratos o penas crueles, inhumanos o degradantes ni a la experimentación médica o científica. Toda persona tiene el derecho al libre, previo y fundamentado consentimiento para recibir tratamiento médico, incluidas las personas con discapacidad de salud mental. El derecho a no ser sometido a experimentación médica o científica sin su consentimiento libre es absoluto, no derogable, ius cogens e erga omnes.

 

La experimentación médica humana no consentida, que viola los derechos de la persona a la vida, la salud y la integridad personal, es universalmente condenada como una violación del derecho internacional consuetudinario y codificado.

 

La administración involuntaria de los medicamentos sin etiquetas [misbranded, o de marca, pero no marcados o marcados erróneamente] viola el artículo 5 (2) de la Convención Americana y el artículo 7 del PIDCP, así como las normas éticas establecidas por el Código de Nuremberg y la Declaración de Helsinki.

 

Los Estados Unidos y la Ley de Tratados

 

El derecho a no ser sometido a tortura ni a tratos o penas crueles, inhumanos o degradantes ni a la experimentación médica o científica es un principio de derechos humanos que tiene el carácter de jus cogens y, por lo tanto, está intrínsecamente enraizado en la enmienda o derogación del tratado.

 

El artículo 53 de la Convención de Viena sobre el Derecho de los Tratados (firmada en Viena el 23 de mayo de 1969), establece que “A los efectos de la presente Convención, una norma imperativa de derecho internacional general es una norma aceptada y reconocida por la comunidad internacional de los Estados en su conjunto como una norma a partir de la cual no se permite una excepción y que sólo puede modificarse mediante una norma ulterior de derecho internacional general que tenga el mismo carácter.”


Los Estados Unidos han firmado y ratificado el Pacto Internacional de Derechos Civiles y Políticos (PIDCP) y la Convención contra la Tortura y Otros Tratos o Penas Crueles, Inhumanos o Degradantes (Convención de las Naciones Unidas contra la Tortura). Ambos tratados delinean la prohibición de la tortura. El PIDCP especifica específicamente la experimentación no consensual dentro del Artículo 7 del PIDCP.

 

Nadie será sometido a torturas ni a penas o tratos crueles, inhumanos o degradantes. En particular, nadie será sometido sin su libre consentimiento a experimentos médicos o científicos.”

 

Art. 2 del PIDCP establece que "cada Estado Parte [...] se compromete a respetar y garantizar a todos los individuos que se encuentren en su territorio y estén sujetos a su jurisdicción los derechos reconocidos en el presente Pacto .... '

 

El PIDCP no contiene ninguna disposición sobre la terminación o el retiro, y el Comité de Derechos Humanos en la Observación General 26 de 1997 declaró que no había tal intención para que un Estado no pudiera retirarse de ella.

 

Por último, el artículo 103 de la Carta de las Naciones Unidas establece que “en caso de conflicto entre las obligaciones de los Miembros de las Naciones Unidas en virtud de la presente Carta y sus obligaciones en virtud de cualquier otro acuerdo internacional, prevalecer”.

 

El tratado PIDCP debe interpretarse de buena fe y con interpretación liberal para proteger los derechos humanos de las personas vulnerables. El canon de buena fe estipula que los tratados "deben ser mantenidos en la más escrupulosa buena fe", y que un tratado "debe ser interpretado... en una manera de llevar a cabo su propósito manifiesto.”

Si un tratado como el Pacto Internacional de Derechos Civiles y Políticos (PIDCP) tiene el carácter de ley federal suprema y crea o protege derechos individuales, entonces un individuo cuyos derechos, objeto del tratado, han sido violados tiene derecho a un recurso interno judicial. La Cláusula de Supremacía complementa los mecanismos de derecho internacional para hacer cumplir los tratados agregando mecanismos internos. La Cláusula de Supremacía hace que los tratados sean asimilados a los estatutos federales ya la Constitución (ordenamiento jurídico nacional), evitando así las diferencias en los mecanismos de aplicación que de otro modo existirían entre estas formas de derecho. Entre otras cosas, la Cláusula de Supremacía hace que los tratados sean ejecutados en las Cortes de Justicia a pedido de los individuos. Debido a que se refiere a "Jueces", la Cláusula de Supremacía claramente contempla que las Cortes de Justicia harán cumplir los tratados y, de hecho, "la jurisdicción de la Corte de Justicia es, únicamente, decidir sobre los derechos de los individuos.”

 

En el caso de Foster v. Neilson,1 el Jefe de Justicia Marshall reconoció que nuestra Constitución, específicamente la Cláusula de Supremacía, establece la regla general de que los tratados son ejecutables en las Cortes de Justicia de los Estados Unidos, al igual que la Constitución y los estatutos federales.

 

Propósitos y Objetivos del Congreso de los Estados Unidos sobre Derechos Humanos

 

Los Tratados Internacionales de Derechos Humanos firmados y ratificados por los Estados Unidos son claramente una declaración de los propósitos y objetivos del Congreso estadounidense en materia de derechos humanos.

 

Por lo tanto, una interpretación de las obligaciones de los Estados Unidos bajo el Pacto Internacional de Derechos Civiles y Políticos (PIDCP), junto con las normas éticas y legales de la Constitución de los Estados Unidos y la Declaración de Derechos de los Estados Unidos, persona natural y ciudadana de los Estados Unidos, tiene el derecho de presentar esta petición a la Comisión Interamericana de Derechos Humanos en apoyo de sus derechos humanos, tal como se definen en el derecho internacional de los derechos humanos y en las normas consuetudinarias de derechos humanos.

 

Algunos derechos, como el derecho a no ser sometido a torturas y no estar sujeto a la experimentación no consensual, son inderogables y, como tales, no pueden ser suspendidos incluso en tiempos de emergencia nacional. Los derechos humanos, como la prohibición de los crímenes contra la humanidad, la tortura y la experimentación científica o médica no consensual se consideran absolutos. Existen deberes erga omnes implícitos para que los Estados Unidos prohíban la experimentación y la tortura no consensuales.

 

El principio de la prohibición de la experimentación no consensual es fundamentalmente normativo y la práctica generalizada de proteger a los seres humanos se considera legal o moralmente obligatoria - Opinio Iuris.

 

El Congreso de los Estados Unidos ha indicado claramente mediante la ratificación del Pacto Internacional de Derechos Civiles y Políticos (artículo 7) que el propósito y la intención del Congreso es proteger a las personas de la experimentación no consensual.

 

El Congreso de los Estados Unidos también ha implementado el artículo 7 del PIDCP en la legislación nacional para proteger a los seres humanos de la experimentación no consensual - La Regla Común (45 CFR Part 46). El Congreso de los Estados Unidos ha hecho su intención claramente evidente por lo siguiente: 1) la ratificación del Pacto Internacional de Derechos Civiles y Políticos (incluido el artículo 7), 2) la celebración de amplias discusiones sobre la necesidad ética de la protección de los seres humanos, 3) la publicación del Informe Belmont y 4) codificación de la Regla Común.

 

La Regla Común (45 CFR Parte 46) es la legislación federal redactada y entró en vigor bajo los procedimientos constitucionales apropiados y por lo tanto es ejecutables por la Corte.

 

Al legislar La Regla Común a través de un proceso político minucioso y detallado, el gobierno federal de los Estados Unidos ha expresado la voluntad política del pueblo de proteger y defender los derechos de las personas contra la experimentación no consensual.

 

Legislación Nacional

 

El 12 de julio de 1974, se promulgó la Ley Nacional de Investigación de los Estados Unidos (L. 93-348), mediante la creación de la Comisión Nacional para la Protección de los Sujetos Humanos de la Investigación Biomédica y del Comportamiento. Uno de los cargos a la Comisión fue identificar los principios éticos básicos que deberían ser la base de la investigación biomédica y conductual en seres humanos y elaborar directrices que deben seguirse para asegurar que dicha investigación se lleve a cabo de conformidad con esos principios. Al llevar a cabo lo anterior, se solicitó a la Comisión que considerara: (I) los límites entre la investigación biomédica y conductual y la práctica aceptada y rutinaria de la medicina, (ii) el papel de la evaluación de los criterios riesgo-beneficio en la determinación de la idoneidad de la investigación en seres humanos, (iii) directrices apropiadas para la selección de sujetos humanos para participar en dicha investigación y (iv) la naturaleza y la definición del consentimiento informado en diversos contextos de investigación.

 

El Informe Belmont (1976)2 Es una declaración formal del gobierno de los Estados Unidos sobre los estándares éticos y las normas legales aceptadas con respecto al uso de sujetos humanos en la experimentación médica, conductual o científica. El Informe Belmont resume los principios éticos básicos identificados en cuatro días de deliberaciones complementados por las deliberaciones mensuales celebradas durante un período de casi cuatro años. Es una declaración de los principios éticos básicos y las pautas a considerar en el uso de sujetos humanos en la investigación. Se publicó en el Registro Federal para que pudiera convertirse en guía ética para los investigadores, científicos, empleados gubernamentales y Juntas de Revisión Institucional (IRB, por su sigla en inglés).

 

El Informe Belmont identifica tres principios éticos básicos que son particularmente relevantes para la ética de la investigación en seres humanos: los principios de respeto a las personas, la beneficencia y la justicia.

 

Investigación vs Práctica Médica

 

La práctica médica tiene por objeto mejorar el bienestar de un paciente o cliente individual y se espera que tenga una expectativa razonable de éxito. El propósito de la práctica médica, psicológica o psiquiátrica es proporcionar diagnóstico, tratamiento preventivo o terapia a individuos. Dentro de la práctica médica clínica, los médicos son éticamente obligados a obtener libre consentimiento informado previo para cualquier tratamiento.

 

El consentimiento libre, informado y previo para el tratamiento es especialmente importante cuando un clínico se aparta de manera significativa de la práctica estándar o aceptada, o utiliza un medicamento que la FDA no ha aprobado para ese uso. Aunque los profesionales médicos pueden utilizar un medicamento "experimental" (en el sentido de ser nuevo, no probado o diferente), esto no exime al médico de revelar al paciente los posibles riesgos y beneficios del tratamiento y obtener el consentimiento libre, informado y previo. Fracaso en obtener el consentimiento libre, previo e informado adecuado y legal se considera negligencia médica.

 

El proceso de obtención del consentimiento debe comprender tres elementos: información, comprensión y voluntariedad. El consentimiento obtenido por engaño, desinformación o coerción no es legalmente válido. La información suministrada en inglés a un paciente cuyo único idioma es el español no cumple con el aspecto de comprensión del consentimiento informado. Proporcionar información sólo en una terminología científica muy detallada que no es entendida por el laico, tampoco está cumpliendo con el aspecto de comprensión del consentimiento informado. Sin el consentimiento fundamentado, previo y libre, el tratamiento experimental sobre seres humanos está prohibido por la ley de los Estados Unidos. Los medicamentos radicalmente nuevos deben ser objeto de investigación formal en una etapa temprana a fin de determinar si son seguros y eficaces. Por lo tanto, es responsabilidad de los comités de práctica médica exigir que se apliquen los principios éticos del Informe Belmont y se protejan los derechos humanos de los pacientes.

 

Los Estados Unidos han aceptado como norma ética la prohibición de la experimentación científica o médica no consensuada mediante la promulgación de leyes federales que prohíben expresamente tales prácticas – La Regla Común - "La Política Federal para la Protección de los Sujetos Humanos". La Regla Común (45 CFR Part 46) fue adoptada en 1991.

 

La FDA, Promoción [de Medicamentos] Sin Etiqueta y Marcados Erróneamente [Off Label and Misbranded]

 

En los Estados Unidos, los nuevos medicamentos se prueban en ensayos clínicos (estudios de investigación) antes de que sean aprobados por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) para su uso en el público en general.

 

Los ensayos clínicos se realizan para demostrar que el fármaco [droga o medicamento]:

  • Trabaja para tratar una cierta condición médica

  • Funciona como se espera

  • Es seguro cuando se usa según las indicaciones

 

Cuando la FDA está satisfecha de que el fármaco funciona y es seguro, y el fabricante del fármaco crea la etiqueta del fármaco. Esto no es una etiqueta real que se pega a una botella, sino un informe de información muy específica sobre el medicamento. La FDA debe aprobar este informe, que se pone a disposición de todos los profesionales de la salud que prescriben o venden el medicamento. La etiqueta del fármaco proporciona información sobre el medicamento, incluyendo la condición médica específica para la que ha sido aprobado (llamada la(s) indicación(es) de uso), las dosis que se utilizarán y cómo se administrará. Cuando se usa un fármaco de una manera diferente a la descrita en la etiqueta de fármaco aprobada por la FDA, se dice que es un uso "fuera de etiqueta" [off label use].

 

Esto puede significar que el medicamento es:

  • Utilizado para una enfermedad o condición médica diferente

  • Dado de una manera diferente (como por una ruta diferente)

  • Dado en una dosis diferente que en la etiqueta aprobada

 

El uso fuera de la etiqueta de medicamentos aprobados por la FDA [off label use] no está regulado, pero es legal en Estados Unidos y muchos otros países. Aunque es legal que los médicos usen drogas fuera de etiqueta [off label use], no es legal que las compañías farmacéuticas comercialicen (anuncien o promuevan) sus medicamentos para usos fuera de la etiqueta [off label use]. El marketing fuera de la etiqueta [off label marketing] es muy diferente del uso fuera de la etiqueta [off label use]. Algunos de los problemas del uso de drogas fuera de la etiqueta [off label drug use] es que a menudo no refleja el tratamiento de "estándar de atención". Esto podría causar que un paciente tenga un resultado no deseado o malo del tratamiento. La FDA no regula la práctica de la medicina. En general, una vez que la FDA aprueba un medicamento, los médicos licenciados pueden usarlo para cualquier propósito que consideren médicamente apropiado.

 

Uno de los mayores problemas relacionados con el uso generalizado fuera de la etiqueta [off label use] es la falta de información sobre cómo utilizar mejor la droga que no sea por lo que fue aprobado. La etiqueta del medicamento contiene la información que ha sido aprobada por la FDA, y no cubre los usos fuera de la etiqueta. La falta de información sobre el uso de drogas fuera de la etiqueta y los resultados pone a los pacientes en un mayor riesgo de errores de medicación, efectos secundarios y reacciones no deseadas. Para el uso médico apropiado de un medicamento no etiquetado, el médico debe informar adecuadamente al paciente sobre los posibles riesgos de usar el medicamento y sopesarlos en contra de los posibles beneficios. Cuando una Corte de Justica decide que un paciente deberá recibir tratamiento médico con medicamento sin etiqueta [off label drug], el proceso de obtención del consentimiento previo, libre e informado no ocurre. La promoción de medicamentos de prescripción sin etiqueta [misbranded] es muy común en la población vulnerable de las personas que estan bajo la protección de la Corte de Justicia debido al bajo riesgo de detección y bajo riesgo de responsabilidad por negligencia médica.3

 

La promoción de medicamentos sin etiqueta [off label] puede implicar lo siguiente: 1) Pagar incentivos a representantes de ventas basados ​​en ventas para uso fuera de la etiqueta [off label use];4 2) Pagar sobornos [kickbacks] a los médicos para recetar medicamentos para uso fuera de la etiqueta [off label use];5 3) Difundir carteles engañosos promoviendo el uso fuera de la etiqueta [off label use];6 4) Pagar médicos: (a) Pretender ser los autores de artículos sobre usos fuera de la etiqueta [off label uses] cuando los artículos fueron realmente escritos por agentes de los fabricantes; (b) Servir como miembros de "consejos consultivos" que promueven el uso fuera de la etiqueta [off label use]; (c) Viajar a lugares turísticos para escuchar promociones sobre el uso fuera de la etiqueta [off label use]; o (d) Dar conferencias promocionales en favor del uso fuera de la etiqueta [off label use] a compañeros practicantes.7 5) Proporcionar asesoramiento a los prescriptores sobre cómo codificar sus reclamos y documentar sus registros médicos para apoyar el pago de usos fuera de la etiqueta [off label uses] no cubiertos por Medicaid;8 6) Publicación de estudios que demuestren la eficacia de los usos fuera de la etiqueta [off label uses] mientras suprimen los estudios que no muestran eficacia ;9 and 7) Hacer representaciones falsas directamente a Medicaid para influir en las decisiones sobre el pago de medicamentos usados ​​fuera de la etiqueta [off label use].10

 

Derecho a la Salud y a la Libertad de Información

 

En 2009, el Relator Especial sobre el derecho a la salud enfatizó que el derecho a la salud depende del derecho al acceso a la información. El Relator Especial declaró que el consentimiento informado es una "decisión voluntaria y suficientemente informada, que protege el derecho del paciente a participar en la toma de decisiones médicas y asigna deberes y obligaciones asociados a los proveedores de atención médica". La información es un elemento integral del derecho a la salud. La integridad de la información se encuentra entre los componentes necesarios del consentimiento informado.

 

Para obtener el consentimiento fundamentado previo se requiere la divulgación de los beneficios, riesgos y alternativas asociados a un procedimiento médico. La exactitud e integridad de la información es necesaria para el consentimiento informado válido para el tratamiento médico. Sin información científica verídica acerca de los beneficios asociados, los riesgos y alternativas a un procedimiento médico o tratamiento es necesario para que el consentimiento sea válido. La garantía del consentimiento informado es respetar la autonomía, la autodeterminación y la dignidad humana de los individuos. Constituye una violación del derecho del paciente a la salud a actuar, o no actuar, de tal manera que priva al paciente de la información que necesita para proporcionar su consentimiento informado.

 

Además, la retención de los hechos presentados en la evaluación de salud mental que se utilizó para certificar al Peticionario como incapacitado legalmente es también una violación del Artículo 13 de la Convención Americana. Sin los hechos es imposible montar una defensa legal para el paciente. La Comisión Interamericana de Derechos Humanos ha establecido el principio de que "toda persona tiene derecho a acceder a la información sobre sí mismo". Los Estados en el contexto de la Convención Americana deben garantizar el ejercicio de este derecho. La Corte Interamericana de Derechos Humanos estipuló el derecho a "buscar" y "recibir" "información", de conformidad con el Artículo 13 de la Convención, protege el derecho de todas las personas a solicitar acceso a información mantenida por el Estado. Esto incluye el derecho del individuo a recibir dicha información y la obligación positiva del Estado de proporcionarla.

 

En el caso emblemático de Claude-Reyes et al vs. Chile, [el derecho a] la libertad de pensamiento y expresión también está protegido por los Artículos IV de la Declaración Americana y 13 de la Convención Americana.

 

La Convención de las Naciones Unidas sobre los Derechos de las Personas con Discapacidad fue adoptada para promover, proteger y garantizar el pleno goce de los derechos humanos y las libertades fundamentales de todas las personas con discapacidad y promover el respeto de su dignidad inherente. Las Partes en la CDPD deben velar por que las personas con discapacidad puedan ejercer el derecho a la libertad de expresión e incluya "la libertad de buscar, recibir e impartir información e ideas en igualdad de condiciones con los demás y mediante todas las formas de comunicación de su elección."

 

El acceso a información médica científica verídica es esencial para el consentimiento informado del paciente. El acceso irrestricto a la información médica es necesario en la lucha contra la corrupción farmacéutica y el fraude médico, e impacta la salud pública. Alentando y creando un sistema más transparente para la distribución de información médica al público y exigiendo responsabilidad criminal por los esfuerzos engañosos de promoción de etiquetas por parte de la industria farmacéutica, los Estados Unidos podrían comenzar a eliminar la corrupción en la comercialización farmacéutica y los sistemas de salud.

 

En 1990, la Organización Panamericana de la Salud (OPS/OMS), la Oficina Regional de las Américas de la Organización Mundial de la Salud (OMS) y un organismo especializado de la Organización de los Estados Americanos (OEA), patrocinaron la Conferencia Regional sobre Reestructuración de la Atención Psiquiátrica en América Latina América, con la CIDH como copatrocinador. En esa conferencia se aprobó la Declaración de Caracas. La Declaración de Caracas establece normas sobre la protección de los derechos humanos y la salud mental. En cuanto a la atención psiquiátrica, indica que "los recursos, la atención y el tratamiento que se ponen a disposición deben salvaguardar la dignidad personal y los derechos humanos y civiles ... y esforzarse por asegurar que los pacientes permanezcan en sus comunidades". También recomienda que los países reformulen la legislación nacional para garantizar que se protejan los "derechos humanos y civiles de los pacientes mentales".

 

En abril de 1999, la Comisión Interamericana de Derechos Humanos aprobó el Informe N.º 63/99 en el caso de una persona con trastorno mental. Ese informe concluye que es "pertinente aplicar normas especiales para determinar si se han cumplido las disposiciones de la Convención en casos de personas que sufren de enfermedades mentales" o los detenidos en hospitales psiquiátricos que se consideran un grupo particularmente vulnerable. En ese informe, la CIDH interpretó las normas de la Convención Americana que prevén el derecho a la integridad física, el derecho a la vida y el derecho a la protección judicial a la luz de los Principios de Salud Mental. En ese informe, la CIDH interpretó las normas de la Convención Americana que prevén el derecho a la integridad física, el derecho a la vida y el derecho a la protección judicial a la luz de los Principios de Salud Mental. En ese informe, la CIDH también estuvo de acuerdo con la posición del Tribunal Europeo de Derechos Humanos, que ha establecido que el estado de salud de una víctima es un factor importante para determinar si han sido sometidos a castigos o tratos inhumanos o degradantes y por lo tanto concluyó que el encarcelamiento de una persona con discapacidad mental en condiciones deplorables y sin tratamiento médico puede considerarse como trato inhumano o degradante, prohibido por el artículo 5 (2) de la Convención Americana sobre Derechos Humanos.

Marcas Erróneas Criminales y Promoción Fuera de Etiqueta [Off Label Marketing]


Las compañías farmacéuticas tienen una extensa historia criminosa de promoción sin etiqueta [off label marketing] de sus medicamentos psiquiátricos. La comercialización fuera de la etiqueta de medicamentos [off label marketing] es la promoción de estos fármacos para usos que nunca han sido aprobados por la Administración de Alimentos y Medicamentos [Food and Drug Administration - FDA] y para los que no se ha demostrado que sean seguros o eficaces. El uso fuera de la etiqueta [off label use] de estos medicamentos aumentó en los adolescentes, debido a un esfuerzo organizado por la industria farmacéutica para aumentar proactivamente el diagnóstico de la depresión en los adolescentes. Una manera de hacer esto fue a través del programa “Selección de Adolescentes” ["Teen Screen"] hecho a través del sistema de escuelas públicas.

 

El público no se dio cuenta de que estos usos fuera de etiqueta [off label uses] nunca habían sido aprobados por la FDA. La financiación de la investigación farmacéutica es una parte importante del plano de cuentas de las instalaciones de salud mental. Los pacientes están, sin su consentimiento informado previo, inscritos en ensayos clínicos experimentales financiados y controlados por las compañías farmacéuticas. Los médicos no pasan por los pasos necesarios para proteger los derechos del paciente para sujetos humanos en experimentación médica como se requiere en la Regla Común. A menudo, los pacientes no están informados del uso experimental del medicamento. Esto sigue siendo una práctica común en hospitales psiquiátricos y clínicas de salud mental donde hacen intervenciones de salud mental de emergencia. Incluso en la práctica privada, los profesionales de la salud mental no obtienen el consentimiento previo informado del paciente antes de inscribir al paciente en una experimentación clínica poco supervisada con medicamento sin etiqueta [off label clinical use]. Los pacientes no se dan cuenta de que estos medicamentos no habían demostrado ser seguros o eficaces y el uso de estos productos fue esencialmente el uso experimental clínico del producto por sus médicos personales.

 

Las compañías farmacéuticas están siendo penalmente condenadas por el Departamento de Justicia de los Estados Unidos de tergiversaciones flagrantes de la seguridad y la eficacia de sus fármacos y la identificación errónea de su producto [misbranding]. La FDA puede perseguir criminalmente los casos de identificación errónea de medicamentos [misbranding], y las consecuencias pueden ser graves, especialmente cuando la FDA cree que la violación fue cometida con la intención de defraudar o engañar.

 

El Derecho Federal en los Estados Unidos [codificado en el] 21 USC § 331 deja en claro que la ley federal prohíbe "la introducción o entrega para la introducción en el comercio Inter estadual de cualquier alimento, droga, dispositivo, producto de tabaco o cosmético adulterado o sin etiqueta [misbranded]" y "la adulteración o marcación errónea [misbranding] de cualquier alimento, droga, dispositivo, producto de tabaco o cosmético en el comercio interestatal ". Además, [la norma legal codificada en el] 21 USC § 352 (f) estipula que un medicamento se considerará sin etiqueta [misbranded] a menos que su etiquetamiento contenga instrucciones adecuadas para el uso, lo cual típicamente requiere las instrucciones para permitir que un laico use el fármaco con seguridad y para los propósitos para los cuales estaba destinado.

 

En un caso reciente datado de 2012, por ejemplo, Abbott Laboratories Inc. se declaró culpable y acordó pagar 1.500 millones de dólares para resolver su responsabilidad penal y civil por su promoción fuera de etiqueta [off label promotion] [del medicamento conocido como] Depakote. Abbott promovió Depakote para controlar comportamientos en pacientes mayores, con demencia y esquizofrenia, sin evidencia significativa de su efectividad para ese uso, e incluso después de que los datos clínicos establecieran que no era eficaz. La resolución incluye una multa penal y confiscación por un total de 700 millones de dólares y acuerdos civiles con el gobierno federal y los estados por un total de 800 millones de dólares. El CEO y la Junta Directiva de Abbott estan sujetos a la libertad condicionada y las actividades de Abbott están bajo la supervisión por la Corte de Justicia.

 

Separado del arreglo del DOJ, Abbott acordó pagar a 45 estados un total de $ 100 millones para resolver la responsabilidad bajo las leyes estaduales de protección del consumidor. Eso hace que este sea el segundo fraude más importante en una compañía farmacéutica, detrás de los 2.300 millones de dólares de Pfizer en 2010.

 

La empresa mantuvo una fuerza de ventas especializada para comercializar Depakote con fines no autorizados [off label purposes]; concentrándose en los pacientes de demencia ancianos en casas de reposo [hogares de ancianos]. Abbott se ha declarado culpable de marcar erróneamente [misbranding] a Depakote promoviendo el fármaco para controlar la agitación y la agresión en ancianos pacientes de demencia y para tratar la esquizofrenia cuando ninguno de estos usos estaba aprobado por la FDA. La FDA aprobó Depakote para sólo tres usos: convulsiones epilépticas, manía bipolar y la prevención de las migrañas. La FDA nunca aprobó el fármaco como seguro y eficaz para el uso fuera de la etiqueta [off label use] para controlar las alteraciones del comportamiento en pacientes con demencia.

 

En 1999, Abbott se vio obligado a interrumpir un ensayo clínico de Depakote en el tratamiento de la demencia debido a una mayor incidencia de eventos adversos, incluyendo somnolencia (somnolencia), deshidratación y anorexia (pérdida de apetito) experimentada por los participantes del estudio ancianos tratados con Depakote.

 

La promoción sin etiqueta [off-label marketing], del medicamento Depakote, por Abbott, fue multifacética. Abbott formó a su fuerza de ventas para promover Depakote a los proveedores de atención médica ya los empleados de hogares de ancianos como ventaja sobre los fármacos antipsicóticos para controlar la agitación y la agresión en pacientes ancianos de demencia debido a que Depakote no estaba sujeto a ciertas disposiciones de la Ley Omnibus de Reconciliación Presupuestaria de 1987 [the Omnibus Budget Reconciliation Act of 1987 (OBRA)]. Los reglamentos de implementación de la OBRA fueron diseñados para prevenir el uso de medicamentos innecesarios en hogares de ancianos [casas de reposo]. Aprovechando el hecho de que ciertas disposiciones de la OBRA aún no se aplicaban a Depakote, los representantes de ventas de Abbott declararon que al usar Depakote, las residencias podrían evitar las cargas administrativas y los costos de cumplir con OBRA.

 

La compañía firmó contratos que proporcionaban a los proveedores de farmacias de cuidado a largo plazo pagos de descuentos basados ​​en aumentos en el uso de Depakote en hogares de ancianos atendidos por los proveedores. La compañía terminó dando millones de dólares en descuentos a los farmacéuticos en las instalaciones de cuidado a largo plazo que se basaron en aumentos en el uso de la droga en los hogares de ancianos atendidos. Abbott creó programas y materiales para capacitar a los farmacéuticos consultores de los proveedores de farmacias sobre el uso no autorizado [off label use] de Depakote para alentarlos a recomendar el medicamento para este uso no aprobado. Abbott no sólo participó en la promoción fuera de la etiqueta [off label marketing], sino que se dirigió a los pacientes ancianos de demencia y minimizó los riesgos aparentes de sus propios estudios clínicos, poniendo las ganancias por delante de la seguridad del paciente. Abbott ofreció y pagó una remuneración ilegal a los profesionales de la salud ya los proveedores de farmacias de atención a largo plazo para influir indebidamente en el contenido de los programas de Educación Médica Continúa patrocinados por la compañía, en violación del Estatuto Federal Anti-Soborno [the Federal Anti-Kickback Statute].

 

En la declaración de hechos acordada, Abbott también admitió que desde 2001 hasta el 2006, la compañía comercializó la droga Depakote, sin etiqueta [off label], para tratar la esquizofrenia. Abbott financió dos estudios científicos sobre el uso de Depakote para tratar la esquizofrenia y ambos fracasaron en cumplir con los objetivos principales establecidos para el estudio. Cuando el segundo estudio no mostró una diferencia de tratamiento estadísticamente significativa entre los fármacos antipsicóticos usados ​​en combinación con Depakote y fármacos antipsicóticos solos, Abbott esperó casi dos años para notificar a su propia fuerza de ventas sobre los resultados del estudio y otros dos años para publicar esos resultados. Durante este tiempo, Abbott continuó promoviendo la utilización sin etiqueta de la droga Depakote [off-label use] para el tratamiento de la esquizofrenia.



En otro caso penal, Pfizer pagó $ 1.300 millones en multas criminales por [practicar el] "misbranding” (el término legal para la comercialización fuera de la etiqueta [off label]) de drogas. Y eso fue sólo la punta del iceberg, considerando que el paquete total del asentamiento fue de $ 2.3 mil millones al agregar los honorarios y costos del Departamento de Justicia (DOJ) [del Gobierno Federal de los Estados Unidos]. La multa fue tan alta porque Pfizer fue considerado un "delincuente reincidente" después de que siguió promoviendo Lipitor y Viagra para usos fuera de la etiqueta [off label use] después de una solicitud de cesar y desistir estas prácticas por la FDA.

 

Grandes multas criminales de miles de millones de dólares fueron otorgadas por las Cortes de Justicia, pero esto hizo poco para restringir efectivamente la comercialización directa de estos medicamentos para uso fuera de etiqueta [off label use] de los productos farmacéuticos a los consumidores ya los profesionales médicos. Los fabricantes de drogas consideran que las sanciones monetarias son sólo otro costo de hacer negocios. Por lo tanto, las compañías farmacéuticas siguen recaudando enormes sumas de beneficio de los presuntos actos ilegales e incluso después de las condenas penales. Los pacientes no son retirados de estos medicamentos peligrosos. En su lugar, Medicaid y Medicare continúan pagando estos medicamentos fuera de la etiqueta [off label drugs] para el tratamiento de las personal bajo la protección de la Corte de Justicia (incluso después de la persecución penal). Los jueces que dirigen las Cortes de Salud Mental no son advertidos por el Departamento de Justicia que los medicamentos que están forzando las personas bajo la protección de la Corte a tomar han demostrado ser peligrosos para los pacientes y la compañía farmacéutica condenados penalmente.

 

Debido a que las sanciones por sentencia y resolución resultaron ser un impedimento ineficaz de estas prácticas, la FDA y el DOJ comenzaron a encontrar otras formas de tratar de detener a los fabricantes de actividades ilegales en curso. Las agencias federales han comenzado a emplear dos nuevas estrategias: 1) presentar cargos criminales contra ejecutivos rebeldes y 2) impedir que los fabricantes ofensores hagan negocios con o para los varios y múltiples planes de beneficios de prescripción federal (por ejemplo, Medicare, Medicaid) . El gobierno federal de Estados Unidos es el mayor comprador único de drogas en el mundo.

 

La participación del sistema judicial para hacer cumplir estos nuevos medios de disuasión es absolutamente crucial. Por lo tanto, los jueces de familia e sucesiones deben hacer valer el derecho del paciente al consentimiento fundamentado previo libre y el derecho a estar libre de la experimentación no consensual.

 

 

Discriminación de los Discapacitados y Necesidad de Protección

 

Las personas con discapacidad mental son a menudo discriminadas por su condición. De acuerdo con la Convención Interamericana sobre la Eliminación de Todas las Formas de Discriminación contra las Personas con Discapacidad, los Estados están obligados a supervisar adecuadamente la atención y tomar las medidas necesarias para prevenir todo tipo de discriminación. Los pacientes que viven en instituciones psiquiátricas o están recibiendo tratamiento en ellas son particularmente vulnerables a la tortura y otros tipos de tratos crueles, inhumanos o degradantes. Estas personas son más susceptibles al maltrato cuando son hospitalizadas. La autonomía y el derecho a la autodeterminación de los pacientes se ve severamente restringido en las instituciones de salud que afecta la integridad personal. Los Estados tienen el deber de supervisar y garantizar que, en todas las instituciones psiquiátricas, públicas o privadas, se preserve el derecho de los pacientes a recibir un trato digno, humano y profesional y que dichos pacientes estén protegidos contra la explotación, el abuso y la degradación. Los Estados también están obligados a promover la plena integración de esas personas en la sociedad.11 Los derechos de los discapacitados están delineados en las políticas y leyes federales, especialmente en la Ley de los Ciudadanos Americanos Discapacitados [Americans with Disabilities Act (ADA)].

 

El tratado internacional de derechos humanos - La Convención sobre los Derechos de las Personas con Discapacidad (CRPD) fue firmado por el Presidente de Estados Unidos, Barack Obama.12 El artículo 12 de la CDPD afirma el reconocimiento igualitario ante la ley y la capacidad jurídica de las personas con discapacidad. El artículo 13 de la CDPD afirma el acceso efectivo a la justicia de las personas con discapacidad. El artículo 25 especifica que " las personas con discapacidad tienen derecho a gozar del más alto nivel posible de salud sin discriminación por motivos de discapacidad." La Convención sobre los Derechos de las Personas con Discapacidad (CRPD) también protege la integridad de la persona. El artículo 17 de la CDPD establece que toda persona con discapacidad tiene derecho al respeto de su integridad física y mental en igualdad de condiciones con los demás.

 

Con respeto a los individuos en tratamiento psiquiátrico, los Estados Unidos no puede absolverse por completo de sus responsabilidades bajo el derecho internacional de los tratados delegando la responsabilidad legal para las determinaciones de la capacidad legal y la tutela a la ley del estado más que por la ley federal. El gobierno federal de los Estados Unidos todavía tiene la obligación de garantizar y proteger los derechos humanos y garantizar un trato humano. Que la capacidad legal y la tutela se rijan por la ley de los Estados miembros de los Estados Unidos de América, y no por la ley federal, no exime al gobierno federal de su responsabilidad. Los Estados Unidos, como Estado-nación, todavía tiene el deber de ejercer la supervisión y el control sobre las instituciones psiquiátricas públicas y privadas. El sistema judicial o la rama judicial de las instituciones gubernamentales y administrativas de los Estados Unidos no sólo deben proporcionar una supervisión competente de forma periódica sobre el confinamiento y el tratamiento médico, sino también si está justificado.13

1 Foster v. Neilson, 27 U.S. (1 Pet.) 253, 314 (1829)

2 El Informe Belmont se publicó en el Registro Federal, y las reimpresiones se proporcionan a petición de científicos, miembros de Juntas de Revisión Institucional y empleados federales. El Apéndice de dos volúmenes, que contiene los largos informes de expertos y especialistas que asistieron a la Comisión en el cumplimiento de esta parte de su cargo, está disponible como DHEW Publicación No. (OS) 78-0013 y No. (OS) 78-0014, para la venta por el Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

3 Overprescribed: The Human and Taxpayers’ Costs of Antipsychotics in Nursing Homes. (2011, November 30). Hearing Before the Senate Special Committee on Aging. [Testimony of Daniel R. Levinson, Inspector General of the Department of Health and Human Services] http://oig.hhs.gov/testimony/docs/2011/levinson_testimony_11302011.pdf

4 U.S. Department of Justice. (2013, July 30). Wyeth Pharmaceuticals Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2013/July/13-civ-860.html

5 U.S. Department of Justice. (2010, April 27). Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing. [Para. 10]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/April/10-civ-487.html

6 U.S. Department of Justice. (2011, June 9). U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/June/11civ-751.html

7 U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

8 U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

9 U.S. Department of Justice. (2011, March 2). Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations. [Para. 8]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/March/11-civ-270.html

10 U.S. Department of Justice. (2012, April 19). U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx. [Para. 5]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2012/April/12civ-497.html

11 Convención Interamericana para la Eliminación de Todas las Formas de Discriminación contra las Personas con Discapacidad, supra nota 35, Preámbulo y Artículo III (1).

12 El artículo 12 de la Convención afirma el reconocimiento igual ante la ley y la capacidad jurídica de las personas con discapacidad. Los Estados Partes deberían: 1) Reafirmar que las personas con discapacidad tienen derecho a ser reconocidas en todas partes como personas ante la ley. 2) Reconocer que las personas con discapacidad gozan de capacidad jurídica en igualdad de condiciones con los demás en todos los aspectos de la vida. 3) Tomar las medidas apropiadas para facilitar el acceso de las personas con discapacidad al apoyo que puedan necesitar en el ejercicio de su capacidad jurídica. 4) Velar por que todas las medidas relacionadas con el ejercicio de la capacidad jurídica establezcan salvaguardias apropiadas y eficaces para prevenir los abusos de conformidad con el derecho internacional de los derechos humanos. Dichas salvaguardias garantizarán que las medidas relativas al ejercicio de la capacidad jurídica respeten los derechos, la voluntad y las preferencias de la persona, están libres de conflicto de intereses e influencia indebida, son proporcionales y adaptados a las circunstancias de la persona, aplican por el menor tiempo posible y están sujetas a revisión periódica por parte de una autoridad

independiente y imparcial o órgano judicial. Las salvaguardias serán proporcionales a la medida en que tales medidas afecten los derechos e intereses de la persona.

13 Corte Europea de Derechos Humanos, en el caso de Storck v. Germany, Peticion No. 61603/00, Sentencia de 16 de junio de 2005, p. 103. 

USA, District of Columbia - Constitutional Convention

Written Statement for the Record 

Dr. Janet Parker DVM 

District of Columbia - Constitutional Convention 

Woodrow Wilson High School 

June 17, 2016 

I am a resident of the District of Columbia and a citizen of the U.S.A. I am also a person with a disability. 
I, as Executive Director of Medical Whistleblower Advocacy Network, advocate for human rights and am 
a regular reporter to the United Nations and stakeholder in the United Nations Universal Periodic 
Review Process. I am a human rights advocate for persons who are disabled. 

The United States government has systematically denied the residents of the District of Columbia the 
right to enjoy equal political participation in their own national legislature. The residents of the District 
of Columbia— the nation’s capital—are denied the fundamental right to equal suffrage in the U.S. 
Congress. They’re prohibited from voting for and electing representatives to the United States Senate 
and the United States House of Representatives. The residents of the District of Columbia are the only 
U.S. taxpaying citizens denied the right to universal and equal suffrage. 

According the 2015 US Census there is an estimated population of 672,228 persons living in D.C. 
Because approximately 8.2% of the US population are persons with a disability, there are an estimated 
55,122 disabled persons living in the District of Columbia. President Barack Obama signed the 
Convention on the Rights of Persons with Disabilities (CRPD) treaty in 2009 and sent it to the U.S. Senate 
for treaty ratification. Former Senator Bob Dole lead a bipartisan effort of support to secure the 2/3 
Senate vote needed for ratification. There was strong bipartisan support for the ratification of the 
CRPD. Medical Whistleblower Advocacy Network (MWAN), The National Council on Independent Living 
(NCIL), The U.S. International Council on Disabilities (USICD) and many other disability advocates rallied 
for CRPD ratification by the Senate. When the disability advocates gathered in Washington D.C. to ask 
their U.S. Senator from their home states to vote for the ratification of the Convention on the Rights of 
Persons with Disabilities, I, as a citizen of D.C. had no U.S. Senator to express my view or vote for me in 
the CRPD treaty ratification process. Unfortunately, on December 4, 2012 the super-majority needed to 
ratify the CRPD was not reached, but we only lost by a few votes. I, and the other 55,122 disabled 
persons living in the District of Columbia, had no one representing our human rights in the CRPD treaty 
deliberation discussions. 

Because of the lack of voting rights for persons who live in the District of Columbia, no disabled person 
living within the District could actually have direct input into the Senate CRPD ratification process. 
There is no elected person who serves in the Senate for the District. I, as a US citizen, went to US Senate 
Majority Leader Senator Harry Reid’s office the day of the 2014 USICD CRPD rally to express the 
wholehearted support for the treaty by the disabled community in Washington, DC. I had spoken to 
Representative Eleanor Holmes Norton to encourage her to advocate in any way possible for the human 
rights of all disabled persons in the District of Columbia. Because this US Senate vote was on a human 
rights treaty and not regarding domestic legislation, I requested that the District's only elected 
Congressional representative, Eleanor Holmes Norton be allowed to vote in favor of ratification of the 
CRPD. But Representative Eleanor Holmes Norton is a non-voting member of the United States House of 


Representatives. She is only allowed to vote on procedural matters and in congressional committees. 
Thus D.C. Residents have no representation in the U.S. Senate. 

Thus, by denying citizens of the District of Columbia the right to fully participate in the national 
government, the United States of America is not in compliance with international human rights treaties. 
This fundamental human right is guaranteed under Article 25 of the International Covenant on Civil and 
Political Rights (ICCPR). 

Article 25: Every citizen shall have the right and the opportunity, without any of the distinctions 
mentioned in article 2 and without unreasonable restrictions: 

(a) To take part in the conduct of public affairs, directly or through freely chosen representatives; 

(b) To vote and to be elected at genuine periodic elections which shall be by universal and equal 
suffrage and shall be held by secret ballot, guaranteeing the free expression of the will of the electors; 

(c) To have access, on general terms of equality, to public service in his country. 

In addition, the lack of representation for the citizens of D.C. in national government is also not in 
compliance with Articles II and XX of the American Declaration of the Rights and Duties of Man. 

Article II. All persons are equal before the law and have the rights and duties established in this 
Declaration, without distinction as to race, sex, language, creed or any other factor. 

Article XX. Every person having legal capacity is entitled to participate in the government of his country, 
directly or through his representatives, and to take part in popular elections, which shall be by secret 
ballot, and shall be honest, periodic and free. 

The citizens of the District of Columbia should have the effective right to participate, directly or through 
freely chosen representatives and in general conditions of equality, in their national legislature. It has 
long recognized by the international community that representative democracy and its associated 
political rights are essential to the effective realization and protection of human rights. It is the 
participation of citizens in their government which forms the basis and the true support of a democracy. 
Democracy cannot exist without it, for the title to government rests with the people, the only body 
empowered to decide its own immediate and future destiny and to designate its legitimate 
representatives. Neither political life, nor institutional change, nor development planning or the control 
of those who exercise public power can be made without representative government. 

I, as a citizen of the District of Columbia and as a U.S. citizen, support statehood for the citizens of the 
District of Columbia. 

Sincerely, 

Dr. Janet Parker DVM 

 Medical Whistleblower Advocacy Network 

 

Treaty Ratification – CRPD Convention on the Rights of Persons with Disabilities

Medical Whistleblower Advocacy Network 

Treaty Ratification – CRPD 

Convention on the Rights of Persons with 
Disabilities 

Written Testimony 

 

Regarding: MWAN Submission to the 

Civil Society Consultation 

Working Group Six 

U.S. Department of State Marshall Center, Room 1482 

April 27, 2016 

10:00 AM – 12:00 PM 

Medical Whistleblower Advocacy Network 

Contact Name: Dr. Janet Parker DVM 

 

 

Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for human 
rights for disabled persons and other individuals. MWAN provides information, referrals, and 
also direct human rights defender advocacy services. 

 

The United States should ratify the Convention on the Rights of Persons with Disabilities 
(CRPD) without any reservations, understandings or declarations that undermine the treaty. 
There are 57.8 million Americans who experience forms of disabilities, 5.5 million American 
veterans with disabilities, and 1 billion people with disabilities around the world today. 

 

President Barack Obama signed the Convention on the Rights of Persons with Disabilities treaty 
in 2009 and sent it to the U.S. Senate for ratification. Medical Whistleblower Advocacy Network 
(MWAN), The National Council on Independent Living (NCIL) along with many other disability 


advocates including the U.S. International Council on Disabilities (USICD) encouraged the US 
Senate ratification of the CRPD. The National Council on Disability (NCD) has also strongly 
supported and encouraged the ratification of this first international treaty to address disability 
rights. 

 

Former Senator Bob Dole lead a bipartisan effort of support to secure the 2/3 Senate vote needed 
for ratification. Unfortunately on December 4, 2012 the super-majority needed was not reached. 
Again in 2013 Foreign Relations Committee Chairman, Robert Mendez held two successful 
hearings on CRPD ratification, but because of opposition the CRPD was still not passed. 
Committee Chairman Mendez brought the matter again forward in 2014, supported again 
strongly by former Senator Bob Dole and many organizations for the disabled and veterans. 

 

This treaty would extend the values of the Americans with Disabilities Act abroad and improve 
access for Americans with disabilities, including veterans, who live, work or travel abroad. 
Discrimination would become illegal in countries that sign the CRPD. Sidewalks would receive 
curb cuts for wheelchair users and others to cross the street. Bathrooms would become accessible 
and parking will be made available to people with disabilities. 

 

There has been strong bipartisan support for the ratification of this important human rights treaty. 
But due to a mistaken view that it will somehow impose new requirements on the United States 
and current U.S. law, the Senate failed to ratify it. Nothing in the CRPD abridges the defining of 
disability as set forth in the Americans with Disabilities Amendments Act. In reality the treaty 
would not require cumbersome or burdensome regulations, because U.S. law is already more 
detailed and in most respects more comprehensive than the CRPD. But U.S. ratification would 
provide the United States with greater leverage to work with countries to align their framework 
with U.S. disability law and our understanding of the CRPD. 

 

The United States of America must show true global leadership in promoting principles that 
protect the human rights of disabled persons worldwide, by setting an example for other nations 
and ratifying the CRPD. Through ratification of the CRPD the United States of America would 
demonstrate continued leadership for the principles of human rights on a global level. The CRPD 
does not infringe upon U.S. sovereignty. Ratification of the CRPD would actually strengthen the 
position of the United States as a global leader in human rights and encourage other nations in 
the world to follow the example set by the United States of America. 

 

Just as in other treaties that the U.S. has ratified, the CRPD provides a framework within which 
international cooperation may occur, and encourages that within any international development 
assistance program there exists accessibility to persons with disabilities. 

 

The CRPD offers people with disabilities things such as: 

 

o Work and employment 
o Respect for home and the family 
o Freedom from exploitation, violence and abuse 
o Adequate standard of living and social protection 

 

 

o Participation in cultural life, recreation, leisure and sport 
o Living independently and being included in the community 
o Freedom of expression and opinion and access to information 

 


 

Medical Whistleblower Advocacy Network strongly urges the United States Senate to ratify the 
CRPD and thus show U.S. leadership in the worldwide effort to grant protection of human rights 
to those with disabilities. 

 

 

MWAN statement Right to life of the International Covenant on Civil and Political Rights,

Medical Whistleblower Advocacy Network 

 

Statement for consideration by the Human Rights Committee during the half-day 
general discussion in preparation for General Comment No. 36 - Article 6: Right to life of 
the International Covenant on Civil and Political Rights, at its 114th Session, Palais des 
Nations, Room XIX – 14 July 2015. 

 

Presented by 

 

Dr. Janet Parker DVM 

 

 

Medical Whistleblower Advocacy Network greatly appreciates the opportunity to be able 
to provide our input to the Half Day of General Discussion commencing the Committee's 
process of developing its General Comment No. 36 on the "Right to Life" with regard to 
article 6 of the International Covenant on Civil and Political Rights (ICCPR). 

This general comment offers the Committee an opportunity to more fully examine the 
right to life, including the consideration of the principles of equality and non-
discrimination regarding persons within a medical context. Human Subjects of medical 
experimentation are placed at risk when investigating unconfirmed hypotheses about 
treatments. Research subjects can experience serious adverse health effects as a 
result of participation in trials including death, shortened life expectancy, or significant 
decrease in the quality of the person’s life. Patients/Human Subjects can also be placed 
at risk by patterns of investigative medical practices that are premature and based on 
an inadequate understanding of a new technique or new drug – or because of direct 
deceit or fraud by drug or medical device manufacturers about their products. 

A person’s equal enjoyment of the right to life is clearly placed at risk by state’s failures 
to take positive measures to address human subject’s protections in biomedical 
research whether it takes place in a university or governmental agency setting or 
whether it takes place in a clinical therapeutic setting. The persons most vulnerable to 
exploitation as human subjects of medical research are those who are already 
marginalized and disadvantaged. Groups such as migrants, prisoners, Roma, children, 
people with disabilities, racial and ethnic minorities are more likely to be targeted by 
researchers. It is important to put in place international programs, policies and 
strategies to address global systemic violations of human subject’s protections. 

At the end of the Second World War, at the Nuremberg Trials, 23 doctors including Dr. 
Joseph Mengele were placed before the international court for atrocities they committed 
under the guise and pretense of medical science. The Nazi doctors had conducted 
medical experiments on numerous prisoners – especially persons who were Jewish, 
Roma, other minorities and disabled children and adults. 

 


The doctor-patient and doctor-human subject relationship is a relationship in which the 
doctor has great power and authority. In this imbalance of power, ethical violations of 
human rights occur - Including violations of the "Right to Life" with regard to article 6 of 
the International Covenant on Civil and Political Rights (ICCPR). In addition, the 
medical community uses the concept of privacy protections to prevent transparency and 
accountability for their actions. Unequal relationships exist between health researchers 
and their patients. But health practitioners rarely acknowledge this conflict of interest in 
their dual roles as health practitioners who are also doing research on their own 
patients. Vulnerable patients who are used as research subjects within a therapeutic 
doctor-patient relationship are not afforded the same level of protection as other 
research subjects, such as persons participating in university or governmental agency 
research project. A large number of subjects are poor, disabled, children, racial 
minorities and/or prisoners. These unwitting human subjects have been subjected to 
deliberate infection with deadly or debilitating diseases, exposed to biological or 
chemical weapons, exposed to radiation or radioactive chemical, given mind-altering 
chemicals or toxins. Subjects were told that they were receiving “medical treatment” and 
reassured by the doctor who they believed would be acting in their “best interest.” 

 

Time and time again, since the original outcry against these atrocities, we are 
confronted with the reality that researchers, doctors and medical professionals have 
acted unethically and violated basic human rights of patients and human subjects. In 
spite of the Hippocratic Oath to “Do No Harm”, doctors and medical professionals have 
violated the human rights of vulnerable persons. The following are just a few examples: 

 

1932 -1972 U.S.A. - U.S. Public Health Service Tuskegee Study of Untreated Syphilis 
scientific researchers in Guatemala infected hundreds of mental patients with sexually 
transmitted diseases. 

 

1944-1945 Japan - Doctor Akira Makino performed surgery and amputations on 
condemned prisoners, mostly Moro Muslims, including women and children, while he 
was stationed on Mindano. 

 

1946-1948 Guatemala - U.S. Public Health Service study on syphilis where researchers 
enrolled people in studies that involved intentional exposure to STD’s without informing 
them of risks or seeking their consent. 

 

1945-1955 Sweden- The Vipeholm dental experiments patients of Vipeholm Mental 
Hospital 

 

1900 - 1930’s U.S.A. - Indian Health Service doctors treated Native Americans for 
Trachoma, an infectious eye disease, by surgically removed the upper and lower 
eyelids of men, women and children. This was “a serious radical operation” called a 
tarsectomy and was done as a preventative measure on non-symptomatic individuals in 
several American Indian communities. 

 


1950’s U.S.A. - U.S. Air Force’s former Arctic Aeromedical Laboratory attempted to 
identify the role of the thyroid gland in human acclimatization to cold weather gave 
radioactive iodine (Iodine131) to Alaska Natives and Eskimos. Many of the Alaskan 
subjects were non-English-speaking individuals and children, who were unable to 
provide proper consent at the time. 

 

1950’s United Kingdom - human experimentation at Porton Down and death of Ronald 
Maddison. 

 

1966 UK -British anesthesiologist Henry K. Beecher published 22 medical studies in 
which patients had been subjects with no expected benefit to the patient of the 
experiment including infusing patients with live cancer cells. 

 

1970’s Zimbabwe - Depo-Provera was clinically tested on Zimbabwean women and 
then the women were pressured to use it once it was approved. 

 

1989-1991 U.S.A. - Los Angeles study of experimental and unlicensed Measles 
vaccinations on African American and Latino children. 

 

1996 Nigeria - Pfizer non-consensual administration of its experimental meningitis drug 
Trovan for meningitis in Kano. Pfizer eventually paid $75 million to settle claims that 
children were injured or killed by the drug Trovan. 

 

2008 Argentina - Santiago del Estero, seven babies died while taking part in trials for an 
experimental vaccine made by GlaxoSmithKline to prevent pneumonia and related 
diseases. 

 

1994 U.S.A. - The Medical University of South Carolina in Charleston was accused of 
enrolling poor black women into narcotic treatment research without their knowledge. 

1990 – 2005 U.S.A. - The US Department of Defense obtained a waiver that allowed it 
to force 8.9 million ground troops to accept inoculation with experimental anthrax 
vaccines. 

2001 U.S.A. - The Kennedy Krieger Institute in Baltimore encouraged black families to 
move into lead-contaminated housing as part of a study on lead levels in children. 

2003 U.S.A. - Northfield Laboratories set up a nationwide trial of its blood substitute 
PolyHeme. Which was randomly administered by ambulance crews to unconscious 
victims of car accidents, shootings and cardiac arrests. Because of a change in U.S. law 
in 1996, allowed non-consensual research on trauma victims on the pretext that they 
were unconscious and thus unable to give consent. It was later concluded that there 
were more deaths and heart attacks in the individuals who had received PolyHeme than 
those who had not. The blood substitute was therefore not licensed. 


Present – U.S.A. and globally - Use of non-FDA approved psychiatric drugs “off-label” 
on wards of the court, elderly, foster children and school children, prisoners, and other 
minorities. 

 

Medical research and the approval of prescription drugs is a global concern. Much of 
the research done by U.S. pharmaceutical companies is happening worldwide. Africa 
and other nations who are economically disadvantaged have been targeted by large 
international pharmaceutical companies to be sites of clinical testing. However, as 
human rights violations of corporations become known, people in the developing world 
are less willing to become guinea pigs – and for good reason. This fundamental distrust 
lies in the paradox of Hobson’s choice “Experimental medicine or no medicine at all”. 
Often the medical research offered does not fully protect human rights nor provide to 
those participating in the research the full benefits of the findings. This leads to another 
concern regarding the “Right to Life”. In that persons in the developing world are often 
denied innovative therapies and also important research developments regarding 
diseases and conditions important to their communities. Even within the U.S.A., there 
are impacts of the withholding of the potential benefits of research while at the same 
time exploiting those same vulnerable populations as research subjects. This leads to 
unequal access to treatment modalities as well as treatment that is not inclusive of the 
specific needs of those vulnerable populations. 

 


Human subject research includes experiments and observational studies in basic 
biology, clinical medicine, nursing, psychology, and all other social sciences. There are 
various codes for the proper and responsible conduct of human experimentation in 
medical research, the best known of these codes are the Nuremberg Code of 1947,i 
and the World Medical Organization’s Helsinki Declaration of 1964 (revised in 1975).ii 


 


In the U.S.A. the Nuremberg Code and the related Declaration of Helsinki delineates 
what is considered ethical conduct for human subjects’ research and forms the basis for 
the US Code of Federal Regulations - Title 45 Volume 46 (The Common Rule). The 
Nuremberg Code’s influence on global human-rights law and medical ethics has been 
profound. Its basic requirement of informed consent, for example, has been universally 
accepted and is articulated in international law in Article 7 of the United Nations 
International Covenant on Civil and Political Rights (1966). 


 


Informed consent is consent obtained freely, without threats or improper inducements, 
and after appropriate disclosure to the patient of adequate and understandable 
information in a form and language understood by the patient. Engaging in an 
informed-consent process between a clinical doctor and a patient should be an 
essential part of the standard of care in medicine. Informed consent is a process, not 
just a formality, and engaging in that process is of the essence of good medical care. 
Information must be provided to the patient in a timely manner and in accordance with 
the accepted standard of practice among members of the profession with similar 


training and experience. A health care professional may be legally liable if a patient 
does not give "informed consent" to a medical procedure and it results in harm to 
patient even if the procedure is properly performed.iii 

 

Adequate informed-consent process is not just a risk management process, it is good 
medical practice. Informed consent should define risks and potential benefits, but also 
take into consideration alternative treatments. Informed consent is an agreement to do 
something or to allow something to happen, made with complete knowledge of all 
relevant facts, such as the risks involved. There is a general right for all human persons 
to be free of inhuman treatment and individuals also have the legal right to privacy 
under international human rights law. 

 

International human rights case law supports the concept that individuals do have the 
legal right to decide whether a proposed medical treatment will be performed on them. 
The human right to decide one's own treatment does not disappear just because it is 
more convenient or financially more beneficial for the caregivers or for the family 
members of the individual to force treatment. This right to decide to refuse treatment is 
a human right we all enjoy. Mental health treatment under human rights law should be 
the same as other treatments in regards to consent to treatment. But it is a sad fact that 
this right has not necessarily been consistently protected and thus through our mental 
health systems extended to people with mental disabilities. Patients need to have the 
intellectual capacity to understand basic information about their diagnosis and proposed 
treatment. Correspondingly doctors have a responsibility to communicate the 
information in terms the patient can understand and to make efforts to be available to 
answer questions the patient may have. 

 


Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the 
International Ethical Guidelines for Biomedical Research Involving Human Subjects, the 
most recent guidelines promulgated by the World Health Organization and the Council 
for International Organizations of Medical Sciences (1993). The Nuremberg Code 
focuses on the human rights of research subjects, the Declaration of Helsinki focuses 
on the obligations of physician-investigators to research subjects, and the federal 
regulations emphasize the obligations of research institutions that receive federal funds. 

In 1974, the U.S.A. signed a law empowering the National Commission for the 
Protection of Human Subjects of Biomedical and Behavioral Research (hereafter called 
the National Commission or Commission) was charged by the U.S. Congress to identify 
the basic ethical principles that should underlie the conduct of research involving human 
subjects. In response to this charge, the National Commission published the Belmont 
Report in the Federal Register on 18 April 1979. The Belmont Report iv concerning the 
Ethical Principles and Guidelines for the protection of human subjects of research. The 
Belmont Report admits that research involving human subjects always inherently 
includes ethical issues and raises moral problems. The Belmont report delineates 3 
major principles: Respect for persons, Beneficence and Justice. The Belmont report 
explains ethics in a manner which is understandable to a diverse group of professionals 
and is reflective of a common morality. It provides a strong protection regarding 


informed consent and also discusses justice and injustice in regards to vulnerable 
populations. Belmont was then adopted in its entirety as a policy statement by U.S. 
Department of Health, Education, and Welfare (DHEW) - now called the Department for 
Health and Human Services (DHHS). Its principles of respect for persons, beneficence, 
and justice are regarded as the three quintessential requirements for the ethical conduct 
of research involving human subjects by the National Institutes of Health (NIH) Office for 
Protection from Research Risks (OPRR). In the US, most research involving human 
participants funded by federal government agencies is subject to the Common Rule — a 
set of regulations delineating the requirements for review by an institutional review 
board. Similar rules apply to research regulated by the Food and Drug Administration 
(FDA). Although US institutions could decline to apply the Common Rule to research 
that does not receive federal funding, relatively few do so. 

Yet the real promise of human subjects protections promised by the Belmont Report 
have not been fully realized in the U.S.A. In part, because although there was full 
discussion of the ethical principles involved, the US National Commission choose not to 
address the concerns regarding the practice of medical research within clinical 
therapeutic settings. 

The true lessons of the past do need to be revisited. Take for example, the Tuskegee 
study which was highly publicized in at least 16 research articles which appeared in 
reputable medical journals, such as the Journal of the American Medical Association, 
the New England Journal of Medicine and the American Journal of Public Health. The 
Nuremberg Code had been adopted in 1947 and the ethical principle of informed 
consent was widely accepted by the medical community, yet the National Medical 
Association and its members remained silent to the abuse of human subjects at 
Tuskegee. In spite of the fact that this abuse of human subjects was not hidden from 
view and that the lessons from the Nuremberg trials should have been fresh in people’s 
minds – for 40 years no medical professional or medical association stood up to 
complain about the violations of the human rights of the human subjects. The white 
coat of silence that shields medical professionals meant that if anyone did object, they 
were certainly not going to make their concerns public. So during the Nazi era, doctors 
stood silent while atrocities occurred and then again years later, in the U.S.A., doctors 
were silent for 40 years about the abuses of the African American men in the Tuskegee 
syphilis trials. Racial bias against these poor black men made their abuse at the hands 
of the researchers almost unnoticed. 

 

Concerns for the honesty and integrity of the medical profession are not new. But what 
is different is how complex the provision of medical care has become and the worldwide 
nature of today’s medical community. And thus how difficult it is for the average patient, 
a lay person, to understand whether they are getting safe and effective medical care. 
Even more difficult to comprehend, is the complex environment of medical research, 
which now often uses clinical doctors in their therapeutic settings to research the effects 
of newer drugs and treatments – often before these medications or procedures have 
been fully reviewed by the state’s regulatory agency (in the U.S.A. this is the F.D.A.). 

 


There is a global distribution of pharmaceutical products. Medical research done in one 
nation will be used to obtain regulatory approval in another country. A drug approved 
for use in one country will rapidly acquire acceptance in other countries often through 
reciprocity. Thus if one nation has poor regulatory control over medical products or 
prescription medications, it will affect other nation states as well. A recent report of the 
US Department of Health and Human Services inspector general, indicated that “federal 
health officials did not know how many clinical trials were being conducted, audited 
fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did 
appear, generally showed up long after the tests had been completed.” v In the U.S.A. 
there is an increased use of prescription drugs “off-label” or without the approval for that 
use by the Food and Drug Administration (FDA). This essentially means that these 
drugs have not been proven by scientific evidence to be safe or effective. These “off-
label” medications are quickly marketed in other countries “off-label” as well as in the 
U.S.A. 

 

Deceptive and coercive marketing practices by the pharmaceutical industry are 
common place. The practice of marketing drugs for purposes not backed by science is 
called “off-label promotion.” In addition, the restrictions upon who can prescribe 
psychiatric drugs have been reduced, thus allowing persons with lesser medical 
credentials (such as nurses with prescription authority) to prescribe these mind altering 
drugs. The pharmaceutical industry has provided marketing and promotional 
educational training and materials for those wishing to gain prescription authority to 
prescribe these drugs. This training is biased to sell their product, not to maximize 
patient informed consent and medical safety for the public. 

 

In the U.S.A., doctors routinely prescribe medications based on little evidence of their 
benefit. This is because there are high profit incentives to prescribe newly patented 
medications and many inducements offered by the pharmaceutical companies for 
doctor to prescribe their products. In an examination of off-label prescribing of 160 
common drugs, off-label use was also found to account for 21% of all prescriptions, and 
most off-label drug uses (73%) were shown to have little or no scientific support. The 
highest rates of off-label use were for anticonvulsants (74%), antipsychotics (60%), and 
antibiotics (41%). Atypical antipsychotics and antidepressants were particularly likely to 
be used off-label without strong evidence. vi The very drugs which are most often 
prescribed off-label with little or no scientific support to indicate that the medication is 
truly beneficial to the patient, actually are the same drugs which commonly cause 
serious debilitating medical conditions and even death. 

 

In the U.S.A. the rates of diagnosis of psychiatric disorders in children and the elderly 
has dramatically increased in recent years. Nearly 70 % of the Diagnostic and 
Statistical Manual of Mental Disorders (DSM-V) task force members report having ties 
to the pharmaceutical industry. These drugs are widely prescribed for unapproved uses, 
including other non-approved conditions significantly boosting their sales. These 
prescription drugs do not live up to their marketing promises but instead have been 
known to cause serious, even fatal side-effects, particularly in children and the elderly. 


Lives of some our most vulnerable citizens have been irreparably damaged and many 
have been lost to fatal adverse effects and even to suicide. 

 

All subjects or their representatives who consent to participate in medical research 
should be enabled 1) to freely choose whether or not to become enrolled, 2) to 
comprehend what is being told to them, and 3) to understand essential information 
about what the research entails, what their options are, and so on. 

So when a doctor prescribes an “off-label” drug for a patient in a therapeutic setting but 
is a cooperating doctor in a research protocol to expand the use of that still not yet 
approved medication – how is that not medical research? If that physician received a 
kickback, or research funding, or free educational programs, is that physician still acting 
in the patient’s best interest? If that doctor removes the FDA mandated patient 
information insert from the medication bottle and instead gives the patient a glossy 
brochure printed by the pharmaceutical marketing agency – is that still getting true 
informed consent? If that doctor answers all the patient’s questions based on a script 
and training he got from the pharmaceutical sales representative – is he still actually 
doing medicine or acting as a marketing sales person himself? And if it is medical 
research, doesn’t the patient have the right to know that that medication was never 
found by scientific evidence to be safe or effective and that in reality the patient is 
actually a guinea pig for the pharmaceutical company’s research. 

 

Research can be disguised as “treatment,” but instead actually be a harmful or deadly 
experiment done without the patient’s knowledge or informed consent to treatment. In 
the U.S.A. many medical institutions are allowed to include wards of the State in 
research that presents greater than minimal risk to the subject with no prospect of direct 
benefit for the research subject. Forcing wards of the court to take medications that are 
“off-label” (not approved for that use by the Food and Drug Administration), is 
tantamount to human experimentation on the vulnerable wards of the court. Such 
violations of human subject provisions are routine with many patients in locked state 
and federal institutions given psychiatric drugs for “off-label uses.” Problems of patient 
abuse occur including: excessive dosing for purposes of chemical restraint, poly-
pharmacy with multiple medications, lack of informed consent and the use of medication 
with little or no direct doctor/patient contact. According to the drug data firm IMS 
Health, the 2009 worldwide sales of antipsychotic drugs was $23.25 billion, and the 
largest market for these products is in the U.S.A. Antipsychotics (neuroleptics) are a 
controversial class of drugs, examples include: Risperdal (approved in 1993), Zyprexa 
(1994), Seroquel (1997), Abilify (2002), and Saphris (2009). 

 

All psychotropic medications have the potential to induce serious adverse effects and 
these psychiatric drugs are not of small risk because they cause massive changes in 
the way the brain functions. Long term studies have indicated that there are severe 
debilitating and sometimes fatal effects of these drugs. Possible negative effects are 
minimized or not even discussed at all. There are risks of long term psychological harm, 
physical harm, social harm and economic harm. Many of these drugs cause symptoms 
that can themselves be construed as mental illness. The probability of developing 
Parkinson’s like symptoms is also great. These powerful mind-altering psychotropic 


i Nuremberg Code Directives for Human Experimentation 

ii World Medical Association Declaration Of Helsinki 

medications do cause potentially disabling and life-threatening side effects such as: 
suicide and violence toward others, increased risks of stroke, cardiovascular disease, 
metabolic syndrome, diabetes, acute closed angle glaucoma, seizures, fainting, and 
decreased infection-fighting white blood cells. One adverse effect of these medications 
is neuroleptic malignant syndrome (NMS), a drug induced, toxic, potentially fatal 
condition resulting in renal failure (10% to 38% of NMS patients die). Early recognition 
and immediate emergency medical treatment of NMS is necessary to prevent death. It 
is estimated that that over 50% of individuals with mental illnesses who are prescribed 
psychotropic drugs also have other serious medical conditions requiring other 
medications. It takes medical expertise and experience to properly prescribe and 
monitor these complex medical interactions. Side effects of these drugs include 
somnolence, obesity, and impaired cognition. These psychiatric medications may 
adversely affect the individual's quality of life and even shorten the person's life 
expectancy.vii Thus it is important that over-medication minimized, the views of the 
patient are considered and the quality of life issues explored. So an effective means of 
reviewing the treatment plans is important. 

 

So can we really trust doctors to do what is always in their patient’s best interest? 
Clearly the history of violations of the rights of human subjects would teach us that we 
cannot and therefore some supervision and ethical guidance is necessary. Yet how do 
we know whether physicians and medical professionals are abusing their power in their 
private relationships with their patients and using the therapeutic relationship to coerce 
patients to submit to medical research? 

 

In the U.S.A. the authors of the Belmont Report were aware that monitoring a doctor’s 
actions within the therapeutic relationship with his patient would be very difficult. The 
US Federal Regulations governing scientific research and the protection of human 
subjects does not address many of the difficult ethical questions and the kinds of 
situations that now occur. The Belmont Report can be used to supplement and augment 
the US Federal Regulations in order to provide a source of additional ethical guidance 
for essential protections for human subjects. In addition the US Food and Drug 
Administration could embrace both the Belmont Report and the Nuremberg Code. 

The protection of Human Subjects in biomedical research is clearly a matter of life or 
death and relates to Article 6: Right to life of the International Covenant on Civil and 
Political Rights. 

Dr. Janet Parker DVM 

 

iii Meador v. Stahler and Gheridian (Middlesex Superior Court C.A. No. 88-6450, Mass. 1993) 

iv The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research 

v Harris G. Report assails FDA oversight of clinical trials. New York Times 28 Sept 2007. 
www.nytimes.com/2004/11/19/business/19fda.html 

vi Radley DC, Finkelstein SN, Stafford RS. (2006) “Off-label prescribing among office-based physicians.” 
Arch Intern Med 2006;166: 1021-6. 

vii Jackson, G.R., (2005). Rethinking psychiatric drugs: A guide to informed consent. Bloomington, IN: 
Author House 

 

Disability Rights MWAN Submission to the United Nations Universal Periodic Review of

Medical Whistleblower Advocacy Network 

Disability Rights 

Submission to the United Nations Universal Periodic Review of 

United States of America 

Second Cycle 

Twenty Second Session of the UPR 

Human Rights Council 

April-May 2015 

Submitted by: 

Medical Whistleblower Advocacy Network 

 

Medical Whistleblower Advocacy Network 

Contact Name: Dr. Janet Parker DVM 

 

List the Organizations/Individuals that Endorse this Report: 

Cindi Fisher (M.O.M.S. Movement Of Mothers-and-Others Standing-up-together), Ann Blake-
Tracy Ph.D. (International Coalition for Drug Awareness), Rose West, Tom E. Frenchman II, 
Amber Keohane, Gerald D. Otis, Ph.D., Judith I. Grant, MSN, RN, CS, Edward O. Parsons, 
Kenneth Williams, Shirley Pettus, Angela Davenport, Fredrick Bennett. 

 

Submitting and endorsing organizations jointly endorse this report as a statement of solidarity, 
but do not necessarily endorse every assertion or policy recommendation made herein. 

 


 

I. SUMMARY: 


1. Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for 
human rights for disabled persons and other individuals. MWAN provides information, 
referrals, and also direct human rights defender advocacy services. MWAN has allowed 
victims of human rights violations to directly tell their own stories, assisting them when 
necessary with their time lines, helping them access documents, and doing research and 
analysis of their situations. Some who experienced human rights violations chose to tell 
their stories in their own words on MWAN's internet radio program. MWAN also works 
with other NGO organizations to advocate for the rights of the disabled and promote the 
protection of human rights. 

2. In the last 4 years MWAN has placed representative disability cases in front of various 
state governmental agencies and the Department of Justice with very mixed results. Lack 
of awareness of the human rights issues led to inaction by numerous governmental 
agencies in many cases. Judges varied in their approaches, some chose to side with 
medical authorities and others were willing to consider human rights defenders 
information. In one case from Washington State, the victim's mother presented her story to 
the UN CERD Committee in Geneva and was then granted release of her son from a 
mental hospital and restoration of his rights.

In another case, however, the victim of 
human rights violations did not receive the care he needed in Minnesota and is now dead. 
A third case in Nebraska did eventually get positively resolved. But there were relapses in 
protection and the man still does not have all his needed services – such as day care and 
respite support. A fourth case from Colorado was lost to the guardianship process and 
hindered by direct interference in the mother's life leading to her hospitalization. Issues of 
alleged domestic violence and lack of adequate secure communication have created 
difficulties for MWAD going forward. A fifth case in Connecticut, involves a citizen from 
the Republic of China who was facing capital punishment and in pre-trial detention for 
years. He no longer faces a possible death sentence, as the state of Connecticut has 
abolished the death sentence. However he remains in a state of limbo, with no trial date 
set, due to questions over his demands that he represent himself and his lack of co-
operation with the public defender. 

3. During the process of providing human rights advocacy and human rights defender 
support MWAD was subjected to violations of human rights necessitating a move from the 
state of Kansas to our present location in Washington DC. 

The United States Government should: 

4. Establish an independent federal governmental office for the investigation of Defenders 
of Human Rights complaints which is accountable to all 3 branches of government and 
works closely with the Department of Justice (DOJ) to prevent, investigate, and support 
prosecution of human rights violations. The office should also coordinate the collaborative 
efforts of the many governmental and non-governmental agencies and organizations that 
affect quality of care in health-related settings. 

5. Strengthen all appropriate Offices of Inspector General related to human rights and fund 
investigation of all defenders of human rights complaints. 


6. Cross-training between those in the medical profession, law enforcement, the judiciary 
and other professions to provide more timely and effective investigation, to prosecute 
abuse and corruption, and to protect victims. 

7. (See MWAN JS-14 UPR report Ninth Session of the Working Group on the UPR 
Human Rights Council 22 November – 3 December 2010) 

8. (Recommendation 44. JS-14 indicated that there is no integrated system for the 
protection of human rights defenders and recommended establishing an independent 
federal office to prevent, investigate and prosecute violations against human rights 
defenders. As noted in A/HRC/WG.6/9/USA/3/Rev.1) 

 

II. LEGAL FRAMEWORK 


9. The United Nations Charter and The Universal Declaration of Human Rights, and the 
General Assembly resolution 53/144 of 8 March 1999, adopted the Declaration on the 
Right and Responsibility of Individuals, Groups and Organs of Society to Promote and 
Protect Universally Recognized Human Rights and Fundamental Freedoms, known as the 
Declaration on human rights defenders and subsequent resolutions (see in particular 
resolution 58/178 of 22 December 2003). The U.S.A. has responsibility in relation to 
actions and omissions of non-State actors as provided in Article 12, paragraph 3 and 
Article 13 of the Declaration. 

10. Universal Declaration of Human Rights, Article 204 

11. International Covenant on Civil and Political Rights, Article 22 

12. International Covenant on Civil and Political Rights, Articles 25 and 26 

13. (See MWAN JS-14 UPR report Ninth Session of the Working Group on the UPR 
Human Rights Council 22 November – 3 December 2010) 

 

 


 

III. U.S. COMPLIANCE WITH ITS INTERNATIONAL HUMAN RIGHTS 
OBLIGATIONS 

International Human Rights Treaties 

14. President Barack Obama signed the Convention on the Rights of Persons with 
Disabilities treaty in 2009 and sent it to the U.S. Senate for ratification. Medical 
Whistleblower Advocacy Network (MWAN), The National Council on Independent 
Living (NCIL) along with many other disability advocates rallied the Senate alongside the 
U.S. International Council on Disabilities (USICD).
ii 
Former Senator Bob Dole lead a 
bipartisan effort of support to secure the 2/3 Senate vote needed for ratification. 
Unfortunately on December 4, 2012 the super-majority needed was not reached. Again in 
2013 Foreign Relations Committee Chairman, Robert Mendez held two successful 
hearings on CRPD ratification, but because of opposition the CRPD was not passed. 
Committee Chairman Mendez brought the matter again forward in 2014, supported again 
strongly by former Senator Bob Dole and many organizations for the disabled and 
veterans. 

Freedom of expression, association and peaceful assembly, and the right to 
participate in public and political life 

Election Voting Rights 

15. The efforts to ratify the CRPD highlighted the need for voting rights for the disabled. 
Election reform is much needed in order that people with disabilities can fully participate 
in the voting process. Barriers include: architectural and physical barriers to polling 
centers, lack of accessible technology, discriminatory actions during voting process, 
guardianship laws that bar registration, and discriminatory voter ID practices. 

16. Because of the lack of voting rights for persons who live in the District of Columbia, 
no disabled person living within the District can actually have direct input into the Senate 
CRPD ratification process, as there is no elected person who serves in the Senate for the 
District. The United States government has systematically denied the residents of the 
District of Columbia the right to enjoy equal political participation in their own national 
legislature.
iii 
The approximately 620,000 residents of the District of Columbia— the 
nation’s capital—are denied the fundamental right to equal suffrage in the U.S. 
Congress.
iv 
They’re prohibited from voting for and electing representatives to the United 
States Senate and the United States House of Representatives. The residents of the District 
of Columbia are the only U.S. taxpaying citizens denied the right to universal and equal 
suffrage— fundamental rights guaranteed under Articles 25 and 26 of the ICCPR. 

17. MWAN went to US Senate Majority Leader Senator Harry Reid’s office the day of the 
2014 USICD CRPD rally to express the wholehearted support for the treaty by the 
disabled community in Washington, DC. MWAN also spoke to the District's only elected 
Congressional representative, Eleanor Holmes Norton, to encourage her to advocate for 
the human rights of all disabled persons in the District of Columbia. 

18. Representative Eleanor Holmes Norton is a non-voting member of the United States 
House of Representatives. She is only allowed to vote on procedural matters and in 
congressional committees. D.C. Residents have no representation in the U.S. Senate. As a 


result of the Twenty-third Amendment to the United States Constitution, adopted in 1961, 
the District is entitled to three electoral votes in the election of the President of the United 
States. There are active efforts to get a D.C. Voting Rights Act passed but equal suffrage 
for D.C. Residents has still not occurred. 

 

Administration of Justice including impunity and rule of law 

Federal and State institutions monitoring human rights 

19. MWAN recommended that an independent human rights institution be established at 
the federal level to ensure implementation of human rights in all states. (JS-14, 
Recommendation 74)

There is currently no integrated system for the protection of human 
rights defenders, which can coordinate investigations, prosecutions and extend protection 
for victims/survivors/witnesses of human rights violations. Currently the Federal 
government does not consistently or systematically review state laws for loopholes that 
provide immunity, or lack of transparency or accountability to persons who violate human 
rights. Instead enforcement of human rights depends on the public's access to the civil 
court system and various governmental agencies to act as civil rights mechanisms for 
review of state laws. Unfortunately, these pathways to justice are not easy to access for 
victims of human rights violations. Many victims of human rights violations never receive 
the protection they need. The court system is costly, cumbersome and slow and difficult to 
navigate for those who are disabled. Some are refused access to the courts because their 
legal rights have been removed from them (wards of the court). Many disabled persons 
struggle to make themselves understood and thus their complaints are often ignored. The 
physical and emotional injuries that many victims endure are likely to affect their ability to 
concentrate, to make sound decisions, to recall events, and to respond to questions about 
their experiences. Mandated reporters of abuse and neglect are not protected when they 
come forward to report human rights issues, instead a culture of impunity often shrouds 
abuse especially in institutions and medical facilities. The state and federal governmental 
agencies do not always respond in a timely or adequate manner. Cross-training is still 
needed between those in the medical profession, law enforcement, the judiciary and other 
professions to provide more timely and effective investigation, to prosecute abuse and 
corruption, and to protect victims. Human rights training and education strategies must be 
incorporated into public policies. 


 

Equality and Non-discrimination 

Mental Health 

20. The US government has a "duty to protect" those who are most vulnerable and to 
provide equal access to treatment and community integration for all those with disabilities 
regardless of what that disability might be. Serious violations and discrimination against 
persons with disabilities are still are occurring on a daily basis, often masked as "good 
intentions" on the part of health professionals. Often authorities employ a substituted 
decision making process that denies the disabled a voice in their own lives. Atrocious 
human rights violations have taken place when people with disabilities are stripped of their 
rights through court facilitated denial of “legal capacity.” Under the existing legal system, 
being placed under guardianship as a ward of the court is sometimes equated to "legal 
death." 
Forced psychiatric treatment, and forced institutionalization can be 
psychologically damaging. State laws allow inpatient and outpatient commitment and 
forced treatment with mind-altering drugs and electroshock for both youth and adults. 
Youth in particular have no right to object to these traumatic and abusive practices. 
Interventions that result in humiliation, isolation, injury and /or pain should not be 
considered appropriate and should not be permitted. 

21. We have as a society often discriminated against certain classes of persons and 
manipulated them into medical research based on their availability to be targeted. Personal 
circumstances that result in their vulnerability include: disability, age, gender, sexual 
orientation, race, ethnicity, religious belief, immigration status, detention or incarceration, 
or financial dependence on welfare. Ethical principles for use of human subjects are now 
delineated in The Common Rule and the Belmont Report, but they are not applied to the 
“extra-label” use of pharmaceutical drugs. Extra label or off label use of psychiatric drugs 
means these drugs have not yet met Food and Drug Administration (FDA) approval for 
that particular use. Many psychiatric medications are often used on patients without their 
full informed consent and often on wards of the court, who essentially have no input into 
medical decisions. Medical professionals also withhold critical information from patients 
and third party decision makers regarding adverse side effects and lack of efficacy for the 
diagnosed problem. 

22. Greater attention should be paid to providing the services that are deemed by the 
disabled themselves to be most beneficial and effective. There should be parity for 
persons wishing to use non-drug interventions and therapies, as well as proper provision of 
community support and resources. Trauma-informed care and peer-run alternatives to the 
traditional medical model do exist. The lack of appropriate services for the disabled, 
however, is often a product of a lack of funding and planning – not because such 
alternatives are impossible to provide. 


 

23. There has been a growing reliance on drug therapy as opposed to non-drug therapies. 
Coercive pharmaceutical management of, and substituted decision making for all disabled 
persons should not be the norm. Third-party decision makers should be held to strict 
constitutional standards of conduct because of the possibility for financial and personal 
conflicts of interest. 

24. Community resources and programs should instead support informed decision making 
regarding the use of medications as well as decreasing reliance on medications and 
restraints. Provision for day care, respite care and in home care for mental patients is 
preferable to institutional care. MWAN supports the recommendation of The National 
Council on Disabilityvi 
to Congress that the U.S.A. move toward a policy of a totally 
voluntary mental health system.
vii 
viii 


Right to Life, Liberty and Security of Person 

Medicaid/Medicare Institutional Bias 

25. Those with disabilities often are not included as equal decision makers when important 
decisions are being made in both health care and housing. There is a bias toward 
institutionalized care by the Centers for Medicaid and Medicare. Medicaid and Medicare 
are federal programs that provide health coverage to low-income children and adults as 
well as long term services and supports for persons with disabilities and low income 
seniors. The Centers for Medicaid and Medicare need to use a definition of community 
integration that permits disabled persons to be fully integrated into the community and 
enjoy the benefits of being able to choose and control their housing options. Instead 
institutional bias in federal Medicaid/Medicare funding now limit access to community 
based services and supports through waiting lists, cost caps and other limitations. The 
result is that disabled persons are forced into institution-like settings such as group homes, 
segregated buildings and other provider-owned facilities. Because the medical community 
is essentially a profit making enterprise with patients paying for services, service provider 
agencies prefer institutionalized services which are paid at a higher rate. In a risk adverse 
environment, the medical establishment encourages the removal of legal rights from the 
disabled and transfer of medical decision-making to third party decision makers. Instead it 
is always preferable to protect autonomy and self-determination. In order to integrate fully 
into the community disabled people often need long term community based supports and 
services. It is inherent in the right to health that all disabled persons should receive 
adequate access to health services including treatment facilities and preventative health 
services. States should be required to provide rehabilitative services and provide assistance 
for daily living activities and health-related tasks, as necessary, to all eligible individuals. 
Third-party decision makers should not be allowed to do involuntary euthanasia by 
withholding life-sustaining treatment. End of life decisions should always be made 
respecting the inherent dignity of person. Nothing is more personal to an individual than 
the moment and circumstances of one’s own death. 


 

Right to Life, Liberty and Security of Person 

 

Excessive Force by Police 

26. On April 29, 2014 MWAN supplied written testimony to the Hearing before the Senate 
Committee on the Judiciary - Subcommittee on the Constitution, Civil Rights and Human 
Rights, “Law Enforcement Responses to Disabled Americans: Promising Approaches for 
Protecting Public Safety." 

27. The public still sees people with psychiatric disabilities as dangerous rather than as 
victims of crime and violence. In most instances, they are more frequently victims of 
violence rather than perpetrators. The assessment of dangerousness must be cautiously 
done with full regard to human rights. Many with mental illness have been shot 
unnecessarily by police. Some protocols call for unnecessary routing of individuals 
directly into the mental health system rather than leaving them to continue their lives in the 
community. If the disabled person is in crisis, then it is important to listen carefully so as 
to discern what is really wrong. Persons who are fearful, are in the moment of their 
distress often not able to accurately describe or articulate what the problem is. 
Unjustifiable pressures for compliance can occur when persons are in positions of 
authority over the disabled person or have commanding influence. Persons with 
diminished autonomy are entitled to protection. A behavioral problem with a disabled 
person may be the first signal to the outside world that there is a serious situation of 
medical fraud, abuse or neglect. Given the possibility that these essential human rights and 
ethical concerns might be being violated, a crisis presented by the disabled person may 
actually need law enforcement scrutiny for proper protection of the person as well as the 
safety of the public at large. 

28. In addition, there needs to be greater scientific study into the increased propensity for 
violence when patients are under the effects of psychiatric drugs. The Food and Drug 
Administration is the Federal regulatory agency involved in approving psychiatric 
medications. Black box warning labels required by the Food and Drug Administration 
were placed on medications due to specific scientific information available to the FDA 
about the possibility of violent thoughts and behaviors, and also risk of suicidal ideation. 

29. These FDA mandated warnings need to be heeded by medical professionals and 
patients alike. Prescription medication package inserts delineating side effects and 
warnings need to be read and understood by patients and third party decision makers. 
Better communication between the local police and the FDA’s adverse event reporting 
system is critical to the protection of patients and also for the safety of the general public. 


 

Right to Life, Liberty and Security of Person 

The Death Penalty 

30. The death penalty was abolished in the state of Connecticut in 2012. 18 states do not 
have the death penalty. 29 states have not had an execution in the last 5 years. 143 
innocent people have been freed from death row.
ix 
MWAN actively protested the death 
penalty in Kansas and attended state congressional hearings on the subject. In Kansas there 
was bipartisan support for abolition and there were almost enough votes to abolish the 
death penalty.

Many were swayed with the argument that it cost more to execute 
someone than to keep him in prison for 40 years and tax payer dollars could be spent in 
better ways.
xi 
Kansas has had no executions since 1976 and has 10 people currently on 
death row, which is costing the state a great deal in legal costs for appeals and public 
defenders. 

31. In 2002 The Supreme Court set the federal standard to protect intellectually disabled 
persons from being executed. The Supreme Court ruled in the Atkins v. Virginia case that 
executing inmates with intellectual disabilities was unconstitutional. However the death 
penalty case being decided by the US Supreme Court in Hall v Florida might open the 
doors to allowing the states to override the federal minimum standard. So persons with 
mental illness or intellectual disabilities may be facing capital punishment when individual 
states attempt to redefine the intellectual minimum standard used for sentencing in capital 
punishment cases, rather than abiding by federal standards. 

Right to Social Security and Adequate Standard of Living 

Housing 

32. For people with disabilities housing has become the single biggest barrier to 
community integration. There has been a continuing disparate impact of lack of affordable 
rental housing primarily due to the foreclosure crisis and shrinking supply of housing 
affordable to low income populations. The Supreme Court in Olmstead v. L.C, 527 U.S. 
581 (1999) held that unnecessary institutionalization constitutes discrimination under the 
Americans with Disabilities Act (ADA). But the United States Department of Housing and 
Urban Development (HUD) has not incorporated the principles of Olmstead and the 
Americans with Disabilities Act fully into their housing policies. 

33. Disabled persons are often extremely low income because they often are totally 
dependent on social programs and when working they earn less than their able bodied 
counterparts. So inadequate incomes and high rents, coupled with the need for accessible 
features in their homes means many disabled are under housed or even homeless. Deep 
cuts in the Fair Housing programs and inadequate funding to The National Housing Trust 
Fund (NHTF) have left many disabled persons homeless or chronically under housed. 
Limited housing subsidies and lack of eviction protections mean that many disabled 
persons are precariously housed, couch surfing, doubling up or in temporary shelter – thus 
at risk of homelessness. 



M.O.M.S. Movement Of Mothers-and-Others Standing-up-together collaborated with 
CHRUSP (Center for the Human Rights of Users and Survivors of Psychiatry) and other 
organizations to submit a paper to the United Nations Committee on the Elimination of Racial 
Discrimination (CERD) in July, 2014. 

Freedom of Movement 

Transportation 

34. Lack of available accessible transportation continues to be a major problem for 
disabled persons. There still remain persistent gaps in compliance with the Americans with 
Disabilities Act. Many who do not have the option to drive a car, therefore are dependent 
on other modes of transportation. Thus the lack of access to affordable dependable 
transportation disproportionately harms the disabled. Because of increased health related 
needs, lack of transportation can negatively impact health and isolate patients from 
providers. Some disabled persons do not leave the house because of unavailability of 
appropriate and affordable transportation. Disabled persons in rural communities are even 
less likely to have adequate accessible transportation, in part due to lack of funding for 
public transportation. Disabled persons need both public and private systems of 
transportation that will provide them with connectivity and independence. 

III. CONCLUSION 


35. The United States government should: 

. Ratify the CRPD without any reservations, understandings or declarations that undermine 
the treaty. 
. Establish a human rights institution at the federal level in order to ensure implementation 
of human rights in all states. (Recommendation 74) 
. Review laws at the Federal and State levels with a view to bringing them in line with its 
international human rights obligations. (Recommendation 65) 
. Incorporate human rights training and education strategies in their public policies. 
(Recommendation 87) 
. Implement the recommendations for a totally voluntary mental health system as 
presented by the National Disability Council 2012 report to Congress National Disability 
Policy: A Progress Report. 
. In death penalty cases, individual state laws, which draw a hard line with IQ ceilings 
should be considered unconstitutional and should not be allowed to override federal law. 
. Address the need for affordable, accessible, integrated housing by funding the National 
Housing Trust Fund and make the Protecting Tenants at Foreclosure Act permanent. 
. Enact such legislation as may be necessary to grant the residents of the District of 
Columbia equal representation in the U.S. Congress, consistent with its obligations under 
Article 25 of the ICCPR. 


 

 

 


 

ii 
U.S. International Council on Disabilities (USICD) www.usicd.org 

 

iii 
"Statement on the subject of The District of Columbia Fair and Equal Voting Rights 
Acts" (PDF) American Bar Association. September 14, 2006. 

iv 
The Inter-American Commission on Human Rights of the Organization of American 
States which on December 29, 2003, concluded in their report that the United States is violating 
the District of Columbia's rights under Articles II and XX of the American Declaration of the 
Rights and Duties of Man by denying District of Columbia citizens an effective opportunity to 
participate in the Congress. [Inter-American Commission on Human Rights (Organization of 
American States) REPORT Nº 98/03] The commission reiterated the following 
recommendation to the United States: "Provide the Petitioners with an effective remedy, which 
includes adopting the legislative or other measures necessary to guarantee to the Petitioners the 
effective right to participate, directly or through freely chosen representatives and in general 
conditions of equality, in their national legislature". 

 


UPR Recommendations Supported by the U.S. Government June 2014 

 

vi 
National Council on Disability, 1331 F Street, NW, Suite 850, Washington, DC 20004 

 

vii 
The National Disability Council’s 2008 report Inclusive Livable Communities for People 
with Psychiatric Disabilities 

 

viii 
The National Disability Council's 2012 statutorily mandated report to Congress National 
Disability Policy: A Progress Report 

ix 
National Coalition to Abolish the Death Penalty, 1620 L. St. NW Ste. 250, Washington, 
DC 20036, 202-331-4090 


Kansas Coalition to Abolish the Death Penalty, Address: P.O. Box 2065 Topeka, KS 
66601-2065, Contact: Mary Sloan, Email: info@ksabolition.org, Phone: 785-235-0214 

xi 
Charles Hamilton Houston Institute for Race & Justice Harvard Law School, “Eleven 
Million Points of Light: How Abolition of the Death Penalty in North Carolina Could Improve 
Public Safety, Increase Opportunities, and Build Prosperity.” A Policy Brief. April 30, 2010. 

 

 

 

Treaties, International Mechanisms and Domestic Implementation UPR 7-20-15

Medical Whistleblower Advocacy Network 

Disability Rights 

Written Testimony regarding 

Treaties, International Mechanisms and Domestic 
Implementation 

UPR Town hall July 20, 2015 

Marshall Center, U.S Department of State, Washington DC 

Regarding: MWAN Submission to the 

United Nations Universal Periodic Review of 

United States of America 

Second Cycle, Twenty Second Session of the UPR 

Human Rights Council 

 

 

Medical Whistleblower Advocacy Network 

Contact Name: Dr. Janet Parker DVM 

 

Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for 
human rights for disabled persons and other individuals. MWAN provides information, 
referrals, and also direct human rights defender advocacy services. 

 

The United States of America has affirmed to the UN General Assembly that all are 
created equal and endowed with inalienable rights. The Americans with Disabilities Act 
(1990) was passed by the US legislature to prohibit discrimination against persons with 
disabilities. Medical Whistleblower Advocacy Network asks that the USA now ratify the 
Convention on the Rights of Persons with Disabilities. The Medical Whistleblower 


Advocacy Network reported in the MWAN 2015 UPR report that: 


"President Barack Obama signed the Convention on the Rights of Persons with 
Disabilities treaty in 2009 and sent it to the U.S. Senate for ratification. Medical 
Whistleblower Advocacy Network (MWAN), The National Council on Independent 
Living (NCIL) along with many other disability advocates rallied the Senate 
alongside the U.S. International Council on Disabilities (USICD). Former Senator 
Bob Dole lead a bipartisan effort of support to secure the 2/3 Senate vote needed 
for ratification. Unfortunately on December 4, 2012 the super-majority needed was 
not reached. Again in 2013 Foreign Relations Committee Chairman, Robert 
Mendez held two successful hearings on CRPD ratification, but because of 
opposition the CRPD was not passed. Committee Chairman Mendez brought the 
matter again forward in 2014, supported again strongly by former Senator Bob 
Dole and many organizations for the disabled and veterans." 

 

Medical Whistleblower Advocacy Network recommends immediate ratification of the 
CRPD as stated in our 2015 UPR report. (UN Summary, Office of the United Nations 
High Commissioner for Human Rights, Human Rights Council, Working Group on the 
Universal Periodic Review, Twenty-second session, 4–15 May 2015, 
A/HRC/WG.6/22/USA/3, JS8 paragraph 4). Medical Whistleblower Advocacy Network is 
concerned that violations, including denial of legal capacity and discrimination against 
persons with disabilities, are still occurring. (A/HRC/WG.6/22/USA/3, JS8 paragraph 
85). 

The following countries endorsed the specific recommendation that the USA ratify the 
Convention on the Rights of Persons with Disabilities (CRPD) (Draft report of the 
Working Group on the Universal Periodic Review United States of America, May 15, 
2015, ( A/HRC/WG.6/22/L.10): 

 

Nepal 5.18 

Sierra Leone 5.19 

Kazakhstan 5.20 

Australia 5.21 

Indonesia 5.24 

Ghana 5.32 

New Zealand 5.32 

Hungary 5.35 

Czech Republic 5.38 

Chile 5.55 

Islamic Republic of Iran 
5.57 

Guatemala 5.59 

Canada 5.59 

Bosnia and Herzegovina 
5.59 

China 5.59 

 

 

 

The following countries wrote in support of the recommendation that the US ratify the 
international human rights instruments from which the US is still not a party (this 
includes the ratification of the CRPD): 

Peru 5.1 

Nicaragua 5.2 

Purinational State of 
Bolivia 5.3 

Germany 5.4 

Viet Nam 5.5 

Israel 5.6 

Panama 5.7 

Tunisia 5.8 

Russian Federation 5.9 

Gabon 5.14 


Bolivarian Republic of 
Venezuela 5.72 

Uruguay 5.74

 

 

The United States does not have a national human rights institution accredited by the 
International Coordinating Committee of National Institutions for the Promotion and 
Protection of Human Rights. Medical Whistleblower Advocacy Network recommends 
that the United States (U.S.A.) establish a national human rights institution in 
accordance with the Paris Principles. Medical Whistleblower Advocacy Network 
recommends also that the U.S.A. review laws at the federal and state levels with a view 
of bringing them in line with US’s international human rights obligations. 
(A/HRC/WG.6/22/USA/3, JS8 paragraph 12) Medical Whistleblower Advocacy Network 
also recommends the establishment of a human rights institution at the federal level in 
accordance with the Paris Principles. Medical Whistleblower Advocacy Network 
supports the recommendation by Cyprus that the USA “Take concrete steps towards 
ratifying the Rome Statute of the International Criminal Court as early as possible.” 
(Cyprus 5.70) 

Medical Whistleblower Advocacy Network recommended incorporating human rights 
training and education strategies in public policies. (A/HRC/WG.6/22/USA/3, JS8 
paragraph 16) 

 

The recommendation by MWAN to create a Federal Human Rights Institution was 
mirrored in multiple recommendations by the following countries: 

Senegal 5.77 

Congo 5.78 

Tunisia 5.78 

Paraguay 5.78 

Chile 5.79 

Bolivarian Republic of 
Venezuela 5.80 

Poland 5.81 

Sierra Leone 5.83 

Republic of Korea 5.84 

Sudan 5.85 

India 5.86 

Nepal 5.86 

Panama 5.86 

Ukraine 5.86 

Democratic Republic of 
the Congo 5.86 

Indonesia 5.86 

Kenya 5.87 

Kazakhstan 5.88 

Gabon 5.89 

Morocco 5.90 

Hungary 5.90 

Nepal 5.92 

Philippines 5.93 

Russian Federation 
5.286 

Medical Whistleblower Advocacy Network had in its first cycle UPR report (2010) 
recommended the following: 

"Medical Whistleblower recommends that the U.S.A. should ratify United Nations 
Convention on the Rights of Disabled Persons (CRDP), the Convention on the 
Rights of the Child (CRC), the Convention on the Elimination of All Forms of 
Discrimination Against Women (CEDAW), the International Covenant on 
Economic, Social and Cultural Rights, The International Convention for the 
Protection of All Persons from Enforced Disappearance, the International 


Convention on the Protection of the Rights of All Migrant Workers and Members of 
Their Families (ICRMW)." 

Many nations also echoed these recommendations by Medical Whistleblower Advocacy 
Network (MWAN) to ratify the Convention on the Rights of the Child (CRC), the 
Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), 
the International Covenant on Economic, Social and Cultural Rights (ICESCR), The 
International Convention for the Protection of All Persons from Enforced Disappearance 
(ICCPED), the International Convention on the Protection of the Rights of All Migrant 
Workers and Members of Their Families (ICRMW). 

These nations included: 

 

Uzbekistan 5.15 

Philippines 5.15 

Trinidad and Tobago 
5.15 

Mauritius 5.16 

Luxembourg 5.17 

Nepal 5.18 

Sierra Leone 5.19 

Kazakhstan 5.20 

Australia 5.21 

Bulgaria 5.22 

India 5.23 

Indonesia 5.24 

Egypt 5.25 

Romania 5.26 

Cabo Verde 5.27 

Togo 5.28 

Paraguay 5.29 

Botswana 5.30 

Iceland 5.31 

Ghana 5.32 

Democratic Republic of 
the Congo 5.33 

New Zealand 5.34 

Hungary 5.35 

Republic of Korea 5.36 

The Former Yugoslav 
Republic of Macedonia 
5.37 

Czech Republic 5.38 

Turkey 5.39 

Iraq 5.39 

Slovenia 5.39 

Bosnia and Herzegovina 
5.39 

France 5.39 

Canada 5.39 

China 5.39 

Trinidad and Tobago 
5.39 

Estonia 5.39 

Lebanon 5.39 

Philippines 5.39 

Austria 5.46 

Mali 5.47 

Sweden 5.48 

Timor-Leste 5.48 

Algeria 5.48 

Maldives 5.48 

France 5.48 

Portugal 5.48 

Slovenia 5.48 

China 5.48 

Japan 5.48 

Canada 5.48 

Philippines 5.49 

Estonia 5.50 

Libya 5.51 

Fiji 5.52 

Czech Republic 5.53 

Honduras 5.54 

Chile 5.55 

Burkina Faso 5.56 

Islamic Republic of Iran 
5.57 

Slovakia 5.58 

 

 

The US Summary of Stakeholder Reports has been posted to the OHCHR website as 
the UN General Assembly Report dated 16 February 2015 of the Human Rights 
Council, Working Group on the Universal Periodic Review, Twenty-second session 4–
15 May 2015. (A/HRC/WG.6/22/USA/3) Medical Whistleblower Advocacy Network is 
listed as a UN stakeholder JS8.